Last update 30 Jun 2024

Duloxetine Hydrochloride

Last update 30 Jun 2024

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

SummaryCYMBALTA® (duloxetine hydrochloride) is an oral medication belonging to the selective serotonin and norepinephrine reuptake inhibitor (SNRI) class. Manufactured by Eli Lilly & Co., it was first approved for use in the US in 2004. CYMBALTA® is indicated for the treatment of major depressive disorder, generalized anxiety disorder in adults and pediatric patients 7 years and older, diabetic peripheral neuropathic pain in adults, fibromyalgia in adults and pediatric patients 13 years and older, and chronic musculoskeletal pain in adults. Its chemical name is (+)-(S)-N-methyl-γ-(1-naphthyloxy)-2-thiophenepropylamine hydrochloride, with the empirical formula C18H19NOS•HCl and molecular weight of 333.88. It works by inhibiting serotonin and norepinephrine reuptake.

Drug Type

Small molecule drug

Synonyms

(3S)-N-methyl-3-(1-naphthyloxy)-3-(2-thienyl)propan-1-amine, (S)-duloxetine, Ariclaim

+ [15]

Target

NET x SERT

Mechanism

NET inhibitors(Norepinephrine transporter inhibitors), SERT inhibitors(Serotonin transporter inhibitors)

Therapeutic Areas

Nervous System DiseasesEndocrinology and Metabolic DiseaseSkin and Musculoskeletal Diseases+ [2]

Active Indication

OsteoarthritisLow Back PainMusculoskeletal Pain+ [12]

Inactive Indication

AlcoholismAnxietyChronic osteoarthritis+ [17]

Originator Organization

Eli Lilly & Co.

Active Organization

Eli Lilly Nederland BV

Zentiva ks

Mylan NV

+ [3]

Inactive Organization

Anchen Pharmaceuticals, Inc.

Esteve Pharmaceuticals S.A.National Institute of Allergy & Infectious Diseases

+ [8]

Drug Highest PhaseApproved

First Approval Date

US (03 Aug 2004),

Depressive Disorder, Major

RegulationPriority Review (CN)

Structure

Molecular FormulaC18H20ClNOS

InChIKeyBFFSMCNJSOPUAY-LMOVPXPDSA-N

CAS Registry136434-34-9

537

Clinical Trials associated with Duloxetine Hydrochloride

NL-OMON31476 / CompletedNot Applicable

Duloxetine plus collaborative care treatment versus Duloxetine alone in the treatment of concomitant pain and depressive disorder. A randomized clinical trial in primary care. - CC:PAINDIP (collaborative care: pain depression in primary healthcare)

Start Date09 Sep 9999

Sponsor / Collaborator-

NCT06407401 / Not yet recruitingPhase 3

Improvement of Quality of Life Through Supportive Treatments for Hormone Therapy - Related Symptoms in Women With Early Breast Cancer; A Pragmatic Randomized Controlled Trial

This study is a pragmatic international, multicenter, randomized, open label 3- arm trial of standard care vs. two pharmacological interventions: duloxetine or furosemide in patients with stage I-III ER+/HER2- early breast cancer with joint, muscle and/or bone pain caused by the endocrine therapy.
The purpose of the BC-QOL trial is to find out whether treatment with duloxetine or furosemide, given while patients are on treatment with endocrine therapy, is active in improving quality of life (QoL), specifically by improving joint, muscle and/or bone pain caused by the endocrine therapy (based on EORTC QLQ-BR42 skeletal scale).

Start Date01 Dec 2024

Sponsor / Collaborator

Eortc

NCT05976347 / Not yet recruitingPhase 4IIT

Identifying and Treating Depression in the Orthopaedic Trauma Population

The goal of this trial is to pilot a way for orthopaedic surgeons to safely screen for depression and provide treatment for depression with medication. The main questions it aims to answer are:
1. What are the outcomes of patients who screen positive for depressive symptoms and are prescribed either an Selective serotonin reuptake inhibitors (SSRI) or serotonin and norepinephrine reuptake inhibitors (SNRI).
2. What are the outcomes of patients who screen positive for depressive symptoms and choose not to pursue treatment with medication?

Start Date01 Jul 2024

Sponsor / Collaborator

Wake Forest School of Medicine

100 Clinical Results associated with Duloxetine Hydrochloride

100 Translational Medicine associated with Duloxetine Hydrochloride

100 Patents (Medical) associated with Duloxetine Hydrochloride

2,979

Literatures (Medical) associated with Duloxetine Hydrochloride

01 Mar 2024·Osteoarthritis and cartilage open

Duloxetine plus exercise for knee osteoarthritis and depression: A feasibility study

Article

Author: Hochberg, Marc C ; Peer, Jason E ; Shardell, Michelle D ; Luborsky, Mark ; Gallo, Joseph J ; Beamer, Brock ; Mehta, Rhea ; Dong, Yu ; Ryan, Alice S ; Rathbun, Alan M ; Golden, Justine

Objective:

To assess the feasibility of a 24-week, center-based, aerobic exercise program plus duloxetine to treat symptomatic knee osteoarthritis (OA) and major depression.

Design:

Patients with symptomatic knee OA and major depression were recruited between August 2021 and November 2022 from the University of Maryland and VA Maryland Health Care Systems and Baltimore metropolitan area using medical records and advertisements. The intervention included 1) supervised treadmill walking 3 times weekly and 2) duloxetine starting at 30 mg each day and titrating up to the optimal dosage of 60 mg daily. Data collection occurred at baseline and 12- and 24-weeks follow-up. Feasibility was evaluated from recruitment rates, reasons for drop out, and treatment adherence. Clinical measures included the Knee Injury and Osteoarthritis Outcome Score (KOOS) and the Hamilton Depression Rating Scale (HAM-D).

Results:

Among 377 interested participants, 9 patients were enrolled, and 1 completed treatment. The most common reason reported for not prescreening was time commitment (n = 39), many patients did not satisfy depression screening criteria (n = 45), and most enrolled participants were not experiencing a major depressive episode (n = 6). The single treated participant was 100 % adherent to duloxetine and depression severity decreased (HAM-D = 25 to 1), but compliance to supervised exercise was only 26 %, and knee pain severity changed little (KOOS = 41.7 to 44.4).

Conclusions:

This intervention had low feasibility. Time commitment to supervised exercise sessions reduced accessibility, and depression defined by diagnostic criteria precluded knee OA patients with depressive symptoms not a meeting case-level diagnosis from receiving treatment.

Clinical trial registration number:

NCT04111627.

01 Mar 2024·North American Spine Society journal

The effect of duloxetine on postoperative pain and opium consumption in spine surgery: A systematic review

Review

Author: Alshohaib, Muntadhar ; Noshahr, Reza Minaei ; Dibamehr, Mohsen ; Kouhestani, Emad

Background:

Postoperative pain after spinal surgery is a major problem that can impact patients' quality of life. Duloxetine is a serotonin and norepinephrine reuptake inhibitor (SNRI) with analgesic effect in different pain disorders. In this study, we aim to evaluate the safety and analgesic effect of duloxetine on acute and chronic pain following spine surgery.

Methods:

A systematic search was completed on MEDLINE, PsycINFO, and Embase through OVID from inception to April 2023 to find relevant articles. We used Cochrane methodology to evaluate the bias of included studies. Investigated outcomes included postoperative pain, opioid consumption, and adverse events.

Results:

Seven articles involving 487 participants were included in our systematic review. Out of 7 papers, 5 were randomized clinical trials, 1 was a pilot trial and 1 was a retrospective observational study. The results of these studies indicated the analgesic effect of duloxetine on postoperative pain, which was measured using numeric rating scale, verbal numeric scale, brief pain inventory, and visual analogue scale. Duloxetine was generally safe without serious adverse events. The most common reported adverse events included headache, nausea, vomiting, itching, dizziness, and drowsiness.

Conclusions:

Duloxetine may be an effective treatment option for postoperative pain following spine surgery, but further rigorously designed and well-controlled randomized trials are required.

01 Mar 2024·Progress in neuro-psychopharmacology & biological psychiatry

A rate-limiting step in antidepressants onset: Excitation of glutamatergic pyramidal neurons in medial prefrontal cortex of rodents

Article

Author: Yan, Jiao-Zhao ; Yin, Yong-Yu ; Cui, Lin-Yu ; Li, Yun-Feng ; Li, Guang-Xiang ; Sun, Si-Rui

Although clinical antidepressants have varied mechanisms of action, it remains unclear whether they may have a common mechanism underlying their antidepressant effects. We investigated the behavioral effects of five different antidepressants (differing in target, chemical structure, and rate of onset) and their effects on the firing activities of glutamatergic pyramidal neurons in the medial prefrontal cortex (mPFC) using the forced swimming test (FST) and electrophysiological techniques (in vivo). We employed fiber photometry recordings to validate the effects of antidepressants on the firing activity of pyramidal neurons. Additionally, multichannel electrophysiological recordings were conducted in mice exhibiting depressive-like behaviors induced by chronic restraint stress (CRS) to investigate whether antidepressants exert similar effects on pyramidal neurons in depressed mice. Behavioral tests were utilized for evaluating the depression model. We found that fluoxetine, duloxetine, vilazodone, YL-0919, and ketamine all increase the firing activities of glutamatergic pyramidal neurons (at least 57%) while exerting their initial onset of antidepressant effects. Fiber photometry revealed an increase in the calcium activity of pyramidal neurons in the mPFC at the onset of antidepressant effects. Furthermore, a significant reduction was observed in the firing activity of pyramidal neurons in the mPFC of CRS-exposed mice, which was reversed by antidepressants. Taken together, our findings suggested that five pharmacologically distinct classes of antidepressants share the common ability to increase the firing activity of pyramidal neurons, just different time, which might be a rate-limiting step in antidepressants onset. The study contributes to the body of knowledge of the mechanisms underlying antidepressant effects and paves the way for developing rapid-acting antidepressants.

News (Medical) associated with Duloxetine Hydrochloride

21 May 2024

·www.biospace.com

Tonix Pharmaceuticals Announces Key Findings from Initial Phase of EVERSANA Market Opportunity Analysis for Tonmya™ for the Management of Fibromyalgia

Tonmya is a potential new first-line, centrally acting non-opioid analgesic for the management of fibromyalgia, supported by statistically significant results from two Phase 3 trials Primary physician research found high level of interest in Tonmya as a potential new treatment option for fibromyalgia Significant dissatisfaction reported with drugs currently approved by FDA for the treatment of fibromyalgia Analysis of claims data revealed that addictive opioids are prescribed more frequently than currently approved drugs following fibromyalgia diagnosis New Drug Application (NDA) submission to the FDA on track for the second half of 2024 CHATHAM, N.J., May 21, 2024 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals, Inc. (Nasdaq: TNXP) (Tonix or the Company), a fully-integrated biopharmaceutical company with marketed products and a pipeline of development candidates, announced today that EVERSANA® Life Science Services, LLC, a leading provider of commercialization services to the global life sciences industry, completed the initial phase of an assessment of the U.S market opportunity for TonmyaTM (also known as TNX-102 SL, cyclobenzaprine HCl sublingual tablets), a potential new first line therapy for the management of fibromyalgia. Tonix previously announced that EVERSANA was selected to support the launch strategy and commercial planning of Tonmya. Specifically, EVERSANA is working with Tonix to assess the fibromyalgia landscape and help plan an efficient go-to-market (GTM) strategy. “The primary research and analysis conducted by EVERSANA provides valuable insights and informs the vision for the commercialization of Tonmya,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “We are excited to refine our business strategy for the anticipated launch of Tonmya in 2025. It has been approximately fifteen years since patients suffering with fibromyalgia have been provided a new therapeutic option. The market research conducted by EVERSANA with physicians indicates a continued high unmet need, with the need ranked > 4.0 on a 5-point scale.” Dr. Lederman continued, “We were surprised to learn that opioids dominate the fibromyalgia prescription market, despite the well-known risks of dependency. Opioids are prescribed to more patients following fibromyalgia diagnosis than all the FDA-approved fibromyalgia drugs combined. If approved, we believe that Tonmya can provide a non-opioid, centrally-acting solution for fibromyalgia patients. This is corroborated by EVERSANA’s primary market research in which physicians indicated median interest of 4.0 on a 5-point scale and intended use of Tomya in 40% of their fibromyalgia patients, upon approval.1 We look forward to submitting the NDA for Tonmya in the second half of this year and expect an FDA decision on approval in 2025.” EVERSANA’s analysis of the market size was based on medical claims databases and epidemiological studies on prevalence and diagnosis2. Primary research with physicians was conducted to test the potential adoption of Tonmya based on its activity and tolerability. Key findings from claims data analyses2: ~2.7 million adults in the U.S. currently diagnosed and treated for fibromyalgia. ~90 percent of patients diagnosed with fibromyalgia are female. Percentage of fibromyalgia patients who were prescribed certain drugs3: FDA-approved fibromyalgia drug prescriptions: Duloxetine (generic Cymbalta®): 23%, pregabalin (generic Lyrica®): 13%, and Savella® (milnacipran): 1% Off-label drug prescriptions: Gabapentin: 26%, hydroxycodone: 20%, cyclobenzaprine: 18%, oxycodone: 19%, tramadol: 13%, meloxicam: 12%, and amitriptyline: 6% Off-label opioids prescriptions: Hydroxycodone: 20%, oxycodone: 19%, and tramadol: 13% Targeted prescriber strategy for launch. High prescribers are rheumatologists, pain medicine specialists, primary care physicians, neurologists, and psychiatrists. ~50 percent of diagnosed fibromyalgia patients are covered by Medicare. Medicare population stands to benefit from a decrease in out-of-pocket prescription drug liability to $2,000 per year when the changes from the Inflation Reduction Act are enacted in 2025. Key findings from primary physician research4: High level of dissatisfaction with currently prescribed drugs. Physicians interviewed estimate that 85% of their patients fail first-line therapy due to efficacy and tolerability issues and 79% of their patients are on multiple therapies. Prescribers indicate high unmet need in fibromyalgia, ranked >4.0 on a 5-point scale. High level of interest in Tonmya from physicians interviewed as a potential new treatment option based on favorable activity and tolerability pro in Tonmya fibromyalgia clinical studies. Median interest in Tonmya of 4 on a 5-point scale. Physicians indicated intended use of Tonmya in 40% of their fibromyalgia patients.1 Tonmya is a centrally acting, non-opioid medication. As previously announced, Tonix’s second statistically significant Phase 3 study, RESILIENT, met its pre-specified primary endpoint, significantly reducing daily pain compared to placebo (p=0.00005) in participants with fibromyalgia. Statistically significant and clinically meaningful results (p=0.001 or better) were also seen in all key secondary endpoints related to improving sleep quality, reducing fatigue, and improving overall fibromyalgia symptoms and function. Tonix plans to submit an NDA to the U.S. Food and Drug Administration (FDA) in the second half of 2024 for Tonmya for the management of fibromyalgia and has scheduled a Type B pre-NDA meeting with FDA for the second quarter of 2024. 1 40% was the median preference share amongphysicians interviewed,assuming no market access barriers. 2EVERSANA analysis of claims database, May 2024; commissioned by Tonix 3Note: the total number of patients is greater than 100% because of switching between medications and polypharmacy. 4EVERSANA primary physician research, May 2024; commissioned by Tonix About Tonmya* (also known as TNX-102 SL) Tonmya is a centrally acting, non-opioid, non-addictive, bedtime medication. The tablet is a patented sublingual formulation of cyclobenzaprine hydrochloride developed for the management of fibromyalgia. In December 2023, the company announced highly statistically significant and clinically meaningful topline results in RESILIENT, a second positive Phase 3 clinical trial of Tonmya for the management of fibromyalgia. In the study, Tonmya met its pre-specified primary endpoint, significantly reducing daily pain compared to placebo (p=0.00005) in participants with fibromyalgia. Statistically significant and clinically meaningful results were also seen in all key secondary endpoints related to improving sleep quality, reducing fatigue and improving overall fibromyalgia symptoms and function. RELIEF, the first positive Phase 3 trial of Tonmya in fibromyalgia, was completed in December 2020. It met its pre-specified primary endpoint of daily pain reduction compared to placebo (p=0.010) and showed activity in key secondary endpoints. *Tonmya™ is conditionally accepted by the U.S. Food and Drug Administration (FDA) as the tradename for TNX-102 SL for the management of fibromyalgia. Tonmya has not been approved for any indication. About EVERSANA® EVERSANA® is a leading independent provider of global services to the life sciences industry. The company’s integrated solutions are rooted in the patient experience and span all stages of the product life cycle to deliver long-term, sustainable value for patients, prescribers, channel partners and payers. The company serves more than 650 organizations, including innovative start-ups and established pharmaceutical companies, to advance life sciences solutions for a healthier world. To learn more about EVERSANA, visit eversana.com or connect through LinkedIn and X. Tonix Pharmaceuticals Holding Corp.* Tonix is a fully-integrated biopharmaceutical company focused on developing, licensing and commercializing therapeutics to treat and prevent human disease and alleviate suffering. Tonix’s development portfolio is focused on central nervous system (CNS) disorders. Tonix’s priority is to submit a New Drug Application (NDA) to the FDA in the second half of 2024 for Tonmya, a product candidate for which two positive Phase 3 studies have been completed for the management of fibromyalgia. TNX-102 SL is also being developed to treat acute stress reaction as well as fibromyalgia-type Long COVID. Tonix’s CNS portfolio includes TNX-1300 (cocaine esterase) a biologic designed to treat cocaine intoxication with Breakthrough Therapy designation. Tonix’s immunology development portfolio consists of biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is a humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) being developed for the prevention of allograft rejection and for the treatment of autoimmune diseases. Tonix also has product candidates in development in the areas of rare disease and infectious disease. Tonix Medicines, our commercial subsidiary, markets Zembrace® SymTouch® (sumatriptan injection) 3 mg and Tosymra® (sumatriptan nasal spray) 10 mg for the treatment of acute migraine with or without aura in adults. *Tonix’s product development candidates are investigational new drugs or biologics and have not been approved for any indication. Zembrace SymTouch and Tosymra are registered trademarks of Tonix Medicines. All other marks are property of their respective owners. This press release and further information about Tonix can be found at . Forward-Looking Statements Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. These forward-looking statements are based on Tonix's current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to the failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; risks related to the failure to successfully commercialize any of our products; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2023, as filed with the Securities and Exchange Commission (the “SEC”) on April 1, 2024, and periodic reports filed with the SEC on or after the date thereof. All of Tonix's forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof. Investor Contact Jessica Morris Tonix Pharmaceuticals investor.relations@tonixpharma.com (862) 904-8182 Peter Vozzo ICR Westwicke peter.vozzo@westwicke.com (443) 213-0505 Media Contact Katie Dodge LaVoieHealthScience kdodge@lavoiehealthscience.com (978) 360-3151 Matt Braun EVERSANA Matt.braun@eversana.com

Phase 3NDAClinical ResultBreakthrough Therapy

01 May 2024

·www.globenewswire.com

Busy Philipps Shines Spotlight on ADHD in Women and Shares her Qelbree Story

Busy is getting candid about navigating her ADHD diagnosis and treatment experience with Qelbree®The percentage of women newly diagnosed with ADHD between 23-29 and 30-49 years of age nearly doubled in just two years (2020-2022)1Although symptoms are present in childhood, a significant portion of women with ADHD don’t receive a diagnosis until they are adults2 ROCKVILLE, Md., May 01, 2024 (GLOBE NEWSWIRE) -- Actress, author, podcaster, and mother of two, Busy Philipps is teaming up with Supernus Pharmaceuticals to share her personal journey with attention-deficit/hyperactivity disorder (ADHD) – one of the most common psychiatric diagnoses in adults – as well as her experience with Qelbree (viloxazine extended-release capsules), a non-stimulant medication for the treatment of ADHD.3 Busy has been vocal about her personal experience living with ADHD for years, but now she is revealing what it means to be a woman navigating ADHD and wants other women who may be struggling to know they are not alone. Boys are two times more likely than girls to be diagnosed.4 While boys’ symptoms often fit the stereotypical ideas of hyperactive ADHD, girls’ inattentive symptoms are often overlooked. As a result, ADHD often goes undiagnosed in young girls, leading to more adult females being undiagnosed and therefore untreated – a sentiment reflective of Busy’s own experience.2,5 “As women, we tend to mask or overcompensate for our ADHD symptoms and end up working harder to get things done. With the right medication, there’s a sense of relief for women with ADHD – you’re suddenly able to take a deep breath," says Busy. "Since I started treatment with Qelbree, I have been able to better manage my ADHD symptoms and understand what to prioritize versus what can be put on the backburner. I'm excited to collaborate with Supernus as a woman navigating ADHD and shed light on the importance of finding the right treatment by empowering others facing similar challenges.” The partnership comes just in time for Mental Health Awareness Month, an important moment to raise awareness around mental health conditions and overall wellness – including approximately 10 million adults living with ADHD in the United States.3 "Supernus seeks to encourage and lift up those living with ADHD to talk to their doctor about managing and treating their condition, especially during Mental Health Awareness Month,” says Jack A. Khattar, President and Chief Executive Officer of Supernus Pharmaceuticals. “We’re excited to see that more women with ADHD, including Busy, are able to manage their ADHD symptoms with the help of Qelbree.” For more information about Qelbree, visit Qelbree.com. Patients should speak to a doctor about all the medications they take, and to see if Qelbree could be right for them. INDICATIONQelbree® (viloxazine extended-release capsules) is a prescription medicine used to treat ADHD in adults and children 6 years and older. IMPORTANT SAFETY INFORMATIONQelbree may increase suicidal thoughts and actions, in children and adults with ADHD, especially within the first few months of treatment or when the dose is changed. Tell your doctor if you or your child have (or if there is a family history of) suicidal thoughts or actions before starting Qelbree. Monitor your or your child’s moods, behaviors, thoughts, and feelings during treatment with Qelbree. Report any new or sudden changes in these symptoms right away. You or your child should not take Qelbree if you or your child:Take a medicine for depression called a monoamine oxidase inhibitor (MAOI) or have stopped taking an MAOI in the past 14 days. Also, you or your child should avoid alosetron, duloxetine, ramelteon, tasimelteon, tizanidine, and theophylline. Qelbree can increase blood pressure and heart rate. Your or your child’s doctor will monitor these vital signs. Qelbree may cause manic episodes in patients with bipolar disorder. Tell your doctor if you or your child show any signs of mania. Do not drive or operate heavy machinery until you know how Qelbree will affect you or your child. Qelbree may cause you or your child to feel sleepy or tired. The most common side effects of Qelbree in patients 6 to 17 years are sleepiness, not feeling hungry, feeling tired, nausea, vomiting, trouble sleeping, and irritability, and in adults, insomnia, headache, sleepiness, tiredness, nausea, decreased appetite, dry mouth, and constipation. These are not all the possible side effects of Qelbree. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. Please see full Prescribing Information, including Boxed Warning, for Qelbree here. 1Russell, J., et al. (2023). Number of ADHD Patients Rising, Especially Among Women. Epic Research.2Holthe, M. E. G., Langvik, E. (2017). The Strives, Struggles, and Successes of Women Diagnosed with ADHD as Adults. SAGE Journals.3Culpepper, L., Mattingly, G. (2010). Challenges in Identifying and Managing Attention-Deficit/Hyperactivity Disorder in Adults in the Primary Care Setting: A Review of the Literature. Primary Care Companion Journal of Clinical Psychiatry.4Reuben C., Elgaddal N. (2024) Attention-deficit/hyperactivity disorder in children ages 5–17 years: United States, 2020–2022. NCHS Data Brief, no 499. Hyattsville, MD: National Center for Health Statistics.5Quinn, P. O., Madhoo, M. (2014). A Review of Attention Deficit/Hyperactivity Disorder in Women and Girls: Uncovering This Hidden Diagnosis. Prim Care Companion CNS Disord. About Supernus Pharmaceuticals, Inc. Supernus Pharmaceuticals is a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases. Our diverse neuroscience portfolio includes approved treatments for epilepsy, migraine, ADHD, hypomobility in Parkinson’s disease (PD), cervical dystonia, chronic sialorrhea, dyskinesia in PD patients receiving levodopa-based therapy, and drug-induced extrapyramidal reactions in adult patients. We are developing a broad range of novel CNS product candidates including new potential treatments for hypomobility in PD, epilepsy, depression, and other CNS disorders. For more information, please visit www.supernus.com. CONTACTS: Jack A. Khattar, President and CEOTimothy C. Dec, Senior Vice President and CFOSupernus Pharmaceuticals, Inc.Tel: (301) 838-2591 Or INVESTOR CONTACT: Peter VozzoICR WestwickeOffice: (443) 213-0505Email: Peter.Vozzo@westwicke.com MEDIA CONTACT: Heidi Donato Tel: (516) 359-1146Email: Heidi.Donato@bcw-global.com

Drug Approval

09 Apr 2024

·www.biospace.com

Seaport Therapeutics Launches with $100 Million Oversubscribed Series A Financing Round to Advance Novel Neuropsychiatric Medicines

Daphne Zohar, Founding CEO of PureTech Health and Co-Founder of Karuna Therapeutics, is Founder, Chief Executive Officer and Member of the Board of Directors of Seaport Steven M. Paul, M.D., former CEO and Chair of Karuna Therapeutics, President of Lilly Research Laboratories, is Founder and Chair of the Board of Directors of Seaport BOSTON--(BUSINESS WIRE)-- Seaport Therapeutics, a clinical-stage biopharmaceutical company that is charting a proven path in neuropsychiatry, today announced the closing of a $100 million oversubscribed Series A financing round. The round was co-led by ARCH Venture Partners and Sofinnova Investments along with Third Rock Ventures and Seaport founder PureTech Health. Seaport also announced the appointment of Daphne Zohar as Founder, Chief Executive Officer and a member of the Board of Directors, and Steven M. Paul, M.D., as Founder and Chair of the Board of Directors. Seaport is advancing a clinical-stage pipeline of novel neuropsychiatric medicines powered by its proprietary Glyph™ Technology Platform, which leverages the lymphatic system to create new medicines building on clinically validated mechanisms. The financing will support the rapid advancement of Seaport’s clinical-stage pipeline of first and best-in-class medicines as well as further development of the Glyph platform, which has demonstrated clinical proof-of-concept. The company is built on a proven development strategy and is led by the team that created and advanced the groundbreaking drug candidate KarXT (xanomeline-trospium), which is now poised to be the first new class of medicine in over 50 years for patients living with schizophrenia. Daphne Zohar, the Chief Executive Officer of Seaport, is the founder and former CEO of PureTech Health where she also co-founded Karuna Therapeutics. Under Ms. Zohar’s leadership, PureTech’s R&D engine led to 28 new medicines, including two that received U.S. FDA clearance and a third (KarXT) that has been filed for FDA approval. Dr. Paul, Founder and Chair of the Seaport Board of Directors, is the former CEO and Chair of the Board of Directors of Karuna Therapeutics, which was recently acquired by Bristol Myers Squibb. Dr. Paul is also the former President of Research and Development at Eli Lilly, where he oversaw the development of CNS drugs such as Zyprexa® and Cymbalta® as well as xanomeline, where its anti-psychotic and pre-cognitive properties were initially demonstrated. "Major depression and anxiety disorders are among the most common, disabling and potentially fatal of all medical conditions. Current standard-of-care treatments provide inadequate relief for far too many patients. Seaport’s pipeline of investigational antidepressants and anxiolytics are well positioned to more effectively treat these disorders and to help millions of people and their families,” said Steven M. Paul M.D. “Given the historically low success rates within neuropsychiatric drug development, precisely solving the previous limitations of clinically validated mechanisms improves the probability of success and enables us to significantly accelerate development.” “We are dedicated to bringing first and best-in-class medicines to those that are suffering from depression, anxiety and other neuropsychiatric disorders,” said Daphne Zohar, Founder and CEO of Seaport Therapeutics. “I’m excited to deliver on this mission along with a stellar team of senior leaders and investors.” All of the programs in Seaport’s pipeline are based on the Glyph platform, which is designed to enable and enhance oral bioavailability, avoid first-pass metabolism and reduce hepatotoxicity and other side effects to advance active drugs that were previously held back by those limitations. Seaport’s most advanced therapeutic candidate is SPT-3001, which is an oral prodrug of allopregnanolone, an endogenous neurosteroid, in development for the treatment of anxious depression. Allopregnanolone has demonstrated therapeutic benefit in a range of neuropsychiatric conditions, but it is only approved as an intravenous infusion, which has limited the scope of its clinical use. Using the Glyph platform, SPT-300 retains the activity and potency of endogenous allopregnanolone in an oral form and has the potential to capture the breadth of the natural biological response. In a Phase 2a clinical trial, SPT-300 demonstrated proof-of-concept in a validated clinical model of anxiety in healthy volunteers. Seaport’s pipeline also includes SPT-3202, a novel prodrug of agomelatine being advanced for the treatment of Generalized Anxiety Disorder, which uses the Glyph platform to bypass first-pass metabolism by the liver and thus has the potential to lower its effective dose, reduce liver exposure and eliminate the need for liver function monitoring that has held back agomelatine. SPT-348, a prodrug of a non-hallucinogenic neuroplastogen in development for the treatment of mood and other neuropsychiatric disorders, leverages Glyph to create a potential first-in-class treatment with improved pharmacokinetics and tolerability compared to conventional psychedelics. Beyond these programs, Seaport has multiple discovery and preclinical programs underway. The additional members joining the Seaport Board of Directors are Robert Nelsen (Managing Partner and Co-founder of ARCH Venture Partners), James Healy, M.D., Ph.D. (Managing Partner of Sofinnova Investments), Eric Elenko, Ph.D. (Co-founder and President of PureTech and Co-inventor of KarXT), and Bharatt Chowrira Ph.D., (newly appointed Chief Executive Officer of PureTech). Courtney Wallace (Venture Partner at Third Rock Ventures) is joining as Board Observer. “I’m thrilled to be partnering again with this outstanding team, led by Daphne and Steve, to change the lives of people with neuropsychiatric disorders,” said Robert Nelsen, Co-founder and Managing Director of ARCH Venture Partners. “We were the lead investors in Karuna’s Series A and Series B financing rounds, and I’m excited to partner with these strong leaders again to deliver on Seaport’s proven strategy and robust pipeline and bring important new medicines to patients.” “Seaport has the potential to meaningfully change the lives of patients with neuropsychiatric disorders,” said James Healy, M.D., Ph.D., Managing Partner at Sofinnova Investments. “We’ve had the pleasure of knowing Steve and Daphne for a number of years, as one of the investors in Karuna, and we believe this team has the unique expertise to help solve the challenges of treating serious mental health conditions. I am eager to support Seaport as an investor and board member as the team continues to advance its clinical-stage pipeline of novel therapeutics.” About the Glyph™ Platform Glyph is Seaport's proprietary technology platform which uses the lymphatic system to enable and enhance the oral administration of drugs. With the Glyph platform, drugs are absorbed like dietary fats through the intestinal lymphatic system and transported into circulation. Seaport believes the Glyph technology has the potential to be widely applied to many therapeutic molecules that have high first-pass metabolism leading to low bioavailability and/or side effects, including hepatotoxicity. The Glyph platform has been refined at Seaport to efficiently generate multiple therapeutic candidates within the company’s pipeline. Seaport has exclusively licensed this technology from Monash University based on the pioneering research of the Porter research group, along with the co-inventors from PureTech Health and Seaport. The group and its collaborators have published research in Nature Metabolism, Frontiers in Pharmacology and the Journal of Controlled Release supporting the Glyph platform's capabilities. About Seaport Therapeutics Seaport Therapeutics is a clinical-stage biopharmaceutical company advancing the development of novel neuropsychiatric medicines in areas of high unmet patient needs. We have a proven strategy of advancing clinically validated mechanisms previously held back by limitations we overcome with our proprietary Glyph™ technology platform. All the therapeutic candidates in our pipeline of first and best-in-class medicines are based on the Glyph platform, which is uniquely designed to enable oral bioavailability, bypass first-pass metabolism and reduce hepatotoxicity and other side effects. We are led by an experienced team that was involved in inventing and advancing KarXT and other neuropsychiatric medicines and are guided by an extensive network of renowned scientists, clinicians and key opinion leaders across neurological specialties. For more information, please visit . Footnotes 1 SPT-300, formerly known as LYT-300 2 SPT-320, formerly known as LYT-320 View source version on businesswire.com: Contacts Seaport Therapeutics publicrelations@seaporttx.com Media Nichole Bobbyn +1 774 278 8273 nichole@tenbridgecommunications.com Source: Seaport Therapeutics View this news release online at:

Phase 2Executive ChangeClinical Result

100 Deals associated with Duloxetine Hydrochloride

External Link

KEGG	Wiki	ATC	Drug Bank
D01179	Duloxetine Hydrochloride	N06AX21	DB00476

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Osteoarthritis	JP	Shionogi & Co., Ltd.	19 Dec 2016
Low Back Pain	JP	Shionogi & Co., Ltd.	18 Mar 2016
Musculoskeletal Pain	IL	Eli Lilly & Co.	07 Nov 2014
Diabetic peripheral neuropathy	US	Eli Lilly & Co.	16 Oct 2014
Back Pain	AR	Eli Lilly & Co.	13 Apr 2014
Diabetic Neuropathies	RU	Eli Lilly & Co.	09 Nov 2011
Chronic musculoskeletal pain	US	Eli Lilly & Co.	04 Nov 2010
Fibromyalgia	US	Eli Lilly & Co.	13 Jun 2008
Anxiety Disorders	AU	Eli Lilly & Co.	14 Mar 2007
Neuralgia	AU	Eli Lilly & Co.	14 Mar 2007
Depressive Disorder	CN	Eli Lilly & Co.	28 Jul 2006
Generalized anxiety disorder	EU	Eli Lilly Nederland BV	17 Dec 2004
Generalized anxiety disorder	EU	Esteve Pharmaceuticals S.A.	17 Dec 2004
Generalized anxiety disorder	IS	Eli Lilly Nederland BV	17 Dec 2004
Generalized anxiety disorder	IS	Esteve Pharmaceuticals S.A.	17 Dec 2004
Generalized anxiety disorder	LI	Eli Lilly Nederland BV	17 Dec 2004
Generalized anxiety disorder	LI	Esteve Pharmaceuticals S.A.	17 Dec 2004
Generalized anxiety disorder	NO	Esteve Pharmaceuticals S.A.	17 Dec 2004
Generalized anxiety disorder	NO	Eli Lilly Nederland BV	17 Dec 2004
Diabetic peripheral neuropathic pain	EU	Eli Lilly Nederland BV	11 Aug 2004

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Chronic osteoarthritis	Phase 3	JP	Eli Lilly & Co.	01 Oct 2014
Chronic Pain	Phase 3	CN	Eli Lilly & Co.	01 Sep 2013
Patellofemoral Pain Syndrome	Phase 3	US	Eli Lilly & Co.	01 Nov 2009
Patellofemoral Pain Syndrome	Phase 3	PR	Eli Lilly & Co.	01 Nov 2009
Obesity	Phase 3	US	Eli Lilly & Co.	01 Sep 2009
Multiple Sclerosis	Phase 3	US	Eli Lilly & Co.	01 Oct 2008
Multiple Sclerosis	Phase 3	BE	Eli Lilly & Co.	01 Oct 2008
Multiple Sclerosis	Phase 3	CA	Eli Lilly & Co.	01 Oct 2008
Multiple Sclerosis	Phase 3	PL	Eli Lilly & Co.	01 Oct 2008
Osteoarthritis, Knee	Phase 3	US	Eli Lilly & Co.	01 Nov 2006

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04313335 (PROCESS Trial, Pubmed)	Not Applicable	Neuralgia, Postherpetic \| Herpes Zoster	-	Duloxetine	fcygzgzdxk(vwfwmsvvxy) = qlwdnjydwn ecglbhenug (exhqjqbrlk )	-	28 Nov 2023
				Duloxetine	fcygzgzdxk(vwfwmsvvxy) = ufziplafqw ecglbhenug (exhqjqbrlk )
NCT02229825 (CTgov)	Phase 4	Depressive Disorder, Major \| Depression	339	Duloxetine (60 mg Duloxetine)	pdlcvnnqou(dteabseoul) = wnjilhxwve umebtwmdtz (ujebcvmhrf, vnmpggfrnl - enzbbzecxj) View more	-	23 Oct 2023
				Duloxetine (120 mg Duloxetine)	pdlcvnnqou(dteabseoul) = serbdlyoeg umebtwmdtz (ujebcvmhrf, ahjilpzzqf - azzskolmmx) View more
NCT03395353 (Pubmed)	Phase 3	Depressive Disorder, Major	151	duloxetine (Japanese pediatric patients with major depressive disorder)	fgrbhvukmb(ysiplrfbaf) = hwlbxtduwq xhcaqduvmb (xsirdnepzb ) View more	-	15 Feb 2023
NCT04178993 (CTgov)	Phase 1	Methamphetamine dependence	8	Placebo oral capsule+Methylphenidate+Methamphetamine (Placebo Comparator: Placebo)	synlvrpsig(lutdhnlxvl) = gmnswsgbrv cxzgzplduk (uksxlcmzjn, kidvmfmuol - gdavkcdztv) View more	-	09 Jan 2023
				Placebo oral capsule+Methylphenidate+Duloxetine+Methamphetamine (Active Comparator: Duloxetine)	ximdaejbtz(kpctqtbbkb) = dfxdyemkwm bwgswxculs (exqbymepso, uummcjomck - iahullbtre) View more
Pubmed	Not Applicable	Pain	82	Duloxetine	bynfogfwue(luslxhindb) = jupgaevcug bcditfthso (gwjrbvhhao )	Positive	21 Nov 2022
				Placebo	bynfogfwue(luslxhindb) = iqepnppavj bcditfthso (gwjrbvhhao )
NCT03271151 (CTgov)	Phase 4	Joint Diseases \| Acute Pain \| Chronic Pain	160	Cymbalta (Duloxetine ("Cymbalta"))	zlhriwtoin(eddwtpwcij) = ivxccupjez rqhrzkhyxy (orrlvilpjh, kqbfqrdnkp - zjblyrrphh) View more	-	26 Apr 2022
				Placebo (Placebo)	zlhriwtoin(eddwtpwcij) = crbrzcnrkm rqhrzkhyxy (orrlvilpjh, gfubbdoutb - sxbkuxjhxc) View more
NCT04697693 (CTgov)	Phase 4	Major depressive disorder, moderate (MDD) \| Stress Disorders, Post-Traumatic \| Depressive Disorder, Major	1	Escitalopram+Duloxetine	szirbhoebn(octzuudzxp) = njzjpuumvg voqjxwsajw (hzruzrqamd, pnomrfmowl - isuhsolmtn) View more	-	28 Mar 2022
NCT03321006 (CTgov)	Phase 4	Cognitive Dysfunction \| Depressive Disorder \| Presbycusis ... View more	25	escitalopram+Audeo B-R 90 hearing aid device (Sham)+Duloxetine (Antidepressant (AD) + Low Amplification (Sham) Hearing Aids)	pfrkitwttt(dodcgnlwdq) = lmdkcdjxjn vhyfpvxxjz (fdunjcbhcx, wyhpovgrtk - vzxyfqhoen) View more	-	19 Aug 2021
				escitalopram+Phonak Audeo B-R 90 hearing aid device (Active)+Duloxetine (Antidepressant (AD) + Full Amplification Hearing Aids)	pfrkitwttt(dodcgnlwdq) = reotzdgsku vhyfpvxxjz (fdunjcbhcx, xbyrygkudt - rayzhkupef) View more
NCT01846182 (CTgov)	Phase 2	Persian Gulf Syndrome	112	Placebo+Duloxetine (Group 1)	awqzpkkouw(brbseajcfp) = pfdwnqbnev trizrzcuud (dykgurboyo, tvdkevahhq - oiybsvhyrf) View more	-	12 Mar 2021
				Placebo+Pregabalin (Group 2)	awqzpkkouw(brbseajcfp) = jtkhfvyexr trizrzcuud (dykgurboyo, czelfoushe - szlvokrtxy) View more
ASCO_GI2021	Not Applicable	Peripheral Nervous System Diseases	53	Duloxetine	lsxegznyjb(gvqlyhlcix) = 5 patients had to stop DL due to G3 drowsiness, insomnia, dry mouth and headache. Overall, DL was well-tolerated with majority of toxicities in G1-2 grade: dizziness (15%), drowsiness (11%), sexual side effects (11%), dry mouth (11%), insomnia (8%), headache (8%) piddjwcgxs (xxuozkgcjq )	Positive	22 Jan 2021

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