A Double-Blind, Randomized, Two-Period Crossover Study to Evaluate the Effects of Tasimelteon Vs. Placebo in Subjects with Delayed Sleep-Wake Phase Disorder (DSWPD) and the CRY1Δ11 Variant

This is a double-blind, randomized, two-period crossover study to evaluate the efficacy and safety of a single oral dose of tasimelteon and matching placebo in male and female subjects with DSWPD and the CRY1Δ11 variant.

Start Date08 Oct 2024

Sponsor / Collaborator

Vanda Pharmaceuticals, Inc.

NCT05922995 / Not yet recruitingEarly Phase 1IIT

A Single Center, Open Label Prospective Observational Pilot Study to Evaluate the Effects of Tasimelteon in Participants With REM Behavior Disorder (RBD)

To assess the effects of a daily single oral dose of 20 mg tasimelteon compared to baseline on events of dream enactment on patients with REM Behavior Disorder, as measured by a daily log.
To assess the effects of 20 mg tasimelteon compared to baseline on insomnia= symptoms, as measured by validated questionnaires (Insomnia Severity Index [ISI], Pittsburgh Sleep Quality Inventory [PSQI], Epworth Sleepiness Scale [ESS], Clinical Global Impression of Change Scale (CGI-C), Patient Global Impression of Change Scale (PGI-C)) as well as rest/activity pattern from actigraphy.
To assess the effects of 20 mg tasimelteon on patients who have a reduced or aberrant melatonin secretion compared to normal secretion by measuring salivary DLMO at baseline and correlating with the degree of change in RBD symptoms by end of the study.
To assess for any role a patient's unique genome may play in their response to tasimelteon; obtained via whole genome sequencing.
To assess the safety and tolerability of a daily single oral dose of 20 mg tasimelteon.

Start Date30 Sep 2023

Sponsor / Collaborator

The Brigham & Women's Hospital, Inc.

[+1]

NCT05572281 / CompletedPhase 1

An Open-Label, Two-Period, Randomized, Single Oral Dose, Crossover Study to Evaluate the Bioequivalence of Tasimelteon Capsule Formulation Relative to Tasimelteon Liquid Suspension Formulation in Healthy Volunteers

This is a single center, two-period, randomized study to evaluate the bioequivalence of a single dose of tasimelteon capsule formulation relative to a single dose of liquid suspension formation in healthy volunteers.

Start Date18 May 2022

Sponsor / Collaborator

Vanda Pharmaceuticals, Inc.

100 Clinical Results associated with Tasimelteon

100 Translational Medicine associated with Tasimelteon

100 Patents (Medical) associated with Tasimelteon

121

Literatures (Medical) associated with Tasimelteon

01 Nov 2024·SCIENCE OF THE TOTAL ENVIRONMENT

Effects of low-molecular-weight organic acids on the transport of polystyrene nanoplastics: An insight at the structure of organic acids

Article

Author: Wei, Xuan ; Gong, Yi ; Lu, Taotao ; Chen, Feiyu ; Chen, Dong

Plastic nanoparticles are extensively used in various products, leading to inevitable pollution in soil. Understanding their transport in soils where various organic substances exist is crucial. This study examined the impact of low-molecular-weight organic acids (LMWOAs) on the transport of polystyrene nanoplastics (PS-NPs) through saturated quartz sand. The experiments involved three dibasic acids-malonic acid (MA₁), malic acid (MA₂) and tartaric acid (TA) - and four monobasic acids- formic acid (FA), acetic acid (AA), propanoic acid (PA) and glycolic acid (GA) -under different pH levels (4.0, 5.5, 7.0) and in the presence of cations (Na⁺, Ca²⁺). The results demonstrated that in the presence of Na⁺, dibasic acids significantly enhanced PS-NPs transport, with TA being the most effective, followed by MA₂ and MA₁. This enhancement is attributed to the adsorption of LMWOAs onto the nanoparticles and sand, creating a more negative ζ-potential, which increases the electrostatic repulsion and decreases the PS-NPs deposition, thereby facilitating the transport. Applying the Derjaguin-Landau-Verwey-Overbeek theory, higher pH levels increased the energy barrier and secondary energy minimum, decreasing PS-NPs deposition. Moreover, dibasic acids significantly enhanced the hydrophilicity of PS-NPs. Conversely, monobasic acids, except for GA, slightly reduced the hydrophilicity of PS-NPs, as indicated by a small increase in the water contact angle, hereby minimally affecting PS-NPs transport. As for GA, although it is a monobasic acid, the additional -OH group in its molecular structure promoted PS-NPs transport, similar to dibasic acids. For example, GA also significantly enhanced the hydrophilicity of PS-NPs. In the presence of Ca²⁺, the enhancement of PS-NPs transport by LMWOAs was comparable to that with Na⁺, primarily due to the complex-forming and bridging effects of Ca²⁺ with the organic acids and PS-NPs. These findings provide important insights into predicting and analyzing the transport behaviors of PS-NPs.

01 Aug 2024·JOURNAL OF PINEAL RESEARCH

Relationship Between Melatonin Receptor Agonists and Parkinson's Disease

Article

Author: Masuda, Rikuto ; Yoshimura, Tomoaki ; Noguchi, Yoshihiro ; Aizawa, Haruka

Abstract:

Parkinson's disease affects millions of people worldwide, and without significant progress in disease prevention and treatment, its incidence and prevalence could increase by more than 30% by 2030. Researchers have focused on targeting sleep and the circadian system as a novel treatment strategy for Parkinson's disease. This study investigated the association between melatonin receptor agonists and Parkinson's disease, using the Food and Drug Administration (FDA) Adverse Events Reporting System (FAERS). The target drugs were melatonin receptor agonists including ramelteon, tasimelteon, and agomelatine. Parkinson's disease cases were defined according to the Medical Dictionary for Regulatory Activities (MedDRA) 25.0; Standardized MedDRA Query (SMQ) using both the “narrow” and “broad” preferred terms (PTs) associated with Parkinson's disease. The association between melatonin receptor agonists (ramelteon, tasimelteon, and agomelatine) and Parkinson's disease was evaluated by the reporting odds ratio. Upon analyzing the data from all patients registered in the FAERS, ramelteon (ROR: 0.66, 95% confidence interval [95% CI]: 0.51–0.84) and tasimelteon (ROR: 0.49, 95% CI: 0.38–0.62) showed negative correlations with Parkinson's disease. Conversely, only agomelatine was positively correlated with Parkinson's disease (ROR: 2.63, 95% CI: 2.04–3.40). These results suggest that among the melatonin receptor agonists, ramelteon and tasimelteon are negatively correlated with Parkinson's disease. In contrast, agomelatine was shown to be positively correlated with Parkinson's disease. These results should be used in research to develop drugs for the treatment of Parkinson's disease, fully considering the limitations of the spontaneous reporting system.

01 Apr 2024·Sleep medicine

Improvement in non-24-h sleep-wake rhythm disorder in a sighted individual treated with a melatonin receptor agonist

Article

Author: Davis, Eric M ; Connolly, Patrick J ; Quigg, Mark

Non-24-hour sleep-wake rhythm disorder (N24SWD) typically presents in patients with visual impairments that disrupt the ability to entrain to the 24 hour solar cycle. We discuss a 43 year old sighted man who presented with periodic daytime hypersomnia and nighttime insomnia, occasionally leading to <3 hours of sleep per day. Previous polysomnography showed an apnea hypopnea index of 6.2 events per hour. A sleep log of 3 months showed irregular time of sleep onset, and an average of 3 hours of sleep per day. Wrist actigraphy confirmed N24SWD. A trial of tasimelteon 20 mg/day resulting in improved daytime hypersomnia (pre-Epworth Sleepiness Scale (ESS) = 21/24, post-ESS = 5/24; a score of > 10/24 is considered sleepy). Follow-up actigraphy showed marked resolution of phase delay with an average of five hours of sleep. The case demonstrates that tasimelteon is a possible treatment for N24SWD in sighted individuals.

News (Medical) associated with Tasimelteon

06 Nov 2024

·www.prnewswire.com

Vanda Pharmaceuticals Reports Third Quarter 2024 Financial Results

Revenues for Q3 2024 were $47.7 million, an increase of 23% compared to Q3 2023 Financial Guidance revised for Full Year 2024, raising the midpoint of revenue and cash ranges Fanapt® launch in bipolar I disorder; new patient starts increased by over 90% in Q3 2024 as compared to Q3 2023 Fanapt® long acting injectable program expected to be initiated in Q4 2024 Milsaperidone NDA for schizophrenia and bipolar I disorder expected to be submitted in early 2025; initiation of major depressive disorder program expected in Q4 2024 PONVORY® commercial launch for multiple sclerosis initiated in Q3 2024 PONVORY® IND applications for psoriasis and ulcerative colitis expected to be submitted in Q4 2024 Tradipitant NDA for motion sickness expected to be submitted in Q4 2024 WASHINGTON, Nov. 6, 2024 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced financial and operational results for the third quarter ended September 30, 2024. "We are very pleased with the lead indicators of the initial market response to our commercial launch of Fanapt in bipolar I disorder, a testament to the strong clinical evidence and the strength of our commercial strategy, and we look forward to continuous growth in the coming quarters. In parallel, we have launched Ponvory for multiple sclerosis and we are looking forward to increased prescriber and patient awareness in the near future. We expect Fanapt, milsaperidone and Fanapt LAI to form a diverse and expanding psychiatry franchise for years to come," said Mihael H. Polymeropoulos, M.D., Vanda's President, CEO and Chairman of the Board. "On the research and development front, we are focused on completing in the coming months our New Drug Applications for tradipitant in motion sickness and for milsaperidone in schizophrenia and bipolar I disorder. IND filings are expected to be completed for Ponvory in ulcerative colitis and psoriasis later this quarter. We are committed to growing our revenue from our existing products and continuing to diversify our sources of revenue through indication expansion and new product development." Financial Highlights Third Quarter of 2024 Total net product sales from Fanapt®, HETLIOZ® and PONVORY® were $47.7 million in the third quarter of 2024, a 23% increase compared to $38.8 million in the third quarter of 2023. Fanapt® net product sales were $23.9 million in the third quarter of 2024, a 12% increase compared to $21.3 million in the third quarter of 2023. HETLIOZ® net product sales were $17.9 million in the third quarter of 2024, a 2% increase compared to $17.5 million in the third quarter of 2023. PONVORY® net product sales were $5.9 million in the third quarter of 2024, a decrease of 32% compared to $8.6 million in the second quarter of 2024. The acquisition of PONVORY® from Actelion Pharmaceuticals Ltd. (Janssen), a Johnson & Johnson Company, was completed on December 7, 2023. Net loss was $5.3 million in the third quarter of 2024 compared to net income of $0.1 million in the third quarter of 2023. Cash, cash equivalents and marketable securities (Cash) was $376.3 million as of September 30, 2024, representing a decrease to Cash of $11.4 million compared to June 30, 2024. The Cash balance of $376.3 million as of September 30, 2024 does not include a payment from Janssen for $8.1 million primarily related to second quarter 2024 PONVORY® revenue receivables, which was received in the fourth quarter of 2024. First Nine Months of 2024 Total net product sales from Fanapt®, HETLIOZ® and PONVORY® were $145.6 million in the first nine months of 2024, a 1% decrease compared to $147.4 million in the first nine months of 2023. Fanapt® net product sales were $67.6 million in the first nine months of 2024, a 1% decrease compared to $68.3 million in the first nine months of 2023. HETLIOZ® net product sales were $56.6 million in the first nine months of 2024, a 28% decrease compared to $79.1 million in the first nine months of 2023. The decrease relative to the first nine months of 2023 was the result of continued generic competition in the U.S. PONVORY® net product sales were $21.3 million in the first nine months of 2024. The acquisition of PONVORY® from Janssen was completed on December 7, 2023. Net loss was $14.0 million in the first nine months of 2024, compared to net income of $4.9 million in the first nine months of 2023. Cash was $376.3 million as of September 30, 2024, representing a decrease to Cash of $12.0 million compared to December 31, 2023. The Cash balance of $376.3 million as of September 30, 2024 does not include a payment from Janssen for $8.1 million primarily related to second quarter 2024 PONVORY® revenue receivables, which was received in the fourth quarter of 2024. Key Operational Highlights Psychiatry Portfolio Fanapt® (iloperidone): Vanda initiated the commercial launch of Fanapt® for the acute treatment of bipolar I disorder in adults in the third quarter of 2024, which included the expansion of its existing sales force and the introduction of prescriber awareness and comprehensive marketing programs. Several lead indicators suggest a strong initial market response including new patient starts as reflected by new to brand prescriptions (NBRx),1 increasing by over 90% in the third quarter of 2024 as compared to the third quarter of 2023. Milsaperidone: Vanda expects to submit a New Drug Application (NDA) for milsaperidone (also known as VHX-896 and P-88), the active metabolite of Fanapt®, for the treatments of schizophrenia and acute bipolar I disorder to the U.S. Food and Drug Administration (FDA) in early 2025. Vanda expects to initiate a Phase III program for milsaperidone for major depressive disorder (MDD) by the end of 2024. Iloperidone long acting injectable (LAI): Vanda expects to initiate a Phase III program for the LAI formulation of Fanapt® in the fourth quarter of 2024. HETLIOZ® (tasimelteon) Vanda has initiated a HETLIOZ LQ® program in pediatric insomnia. Although the prevalence of insomnia in children is difficult to determine, it is estimated that 20-40% of children experience significant sleep problems.2,3 There are currently no approved treatments for pediatric insomnia. Vanda continues to pursue FDA approval for HETLIOZ® for the treatments of jet lag disorder and insomnia. Vanda is challenging the FDA's rejection of Vanda's supplemental New Drug Application (sNDA) for the treatment of jet lag disorder in the U.S. Court of Appeals for the D.C. Circuit. Vanda has accepted the opportunity for a hearing with the FDA on the approvability of the insomnia sNDA. Vanda's litigation asserting HETLIOZ® Patent No. 11,285,129 against generic manufacturers is currently pending in the U.S. District Court for the District of Delaware. A jury trial has been scheduled for the first quarter of 2026. European Medicines Agency action on Vanda's Marketing Authorization Application for HETLIOZ® and HETLIOZ LQ® for Smith-Magenis Syndrome is expected in the first quarter of 2025. PONVORY® (ponesimod) Vanda initiated the commercial launch of PONVORY® for the treatment of relapsing forms of multiple sclerosis in the third quarter of 2024, which included the deployment of a specialty sales force. Vanda expects Investigational New Drug (IND) applications for PONVORY® in the treatments of psoriasis and ulcerative colitis to be completed in the fourth quarter of 2024. Tradipitant Gastroparesis NDA: In September 2024, the FDA declined to approve Vanda's NDA for tradipitant for the treatment of symptoms of gastroparesis. Vanda plans to continue to pursue the marketing authorization for tradipitant and support the expanded access program that is currently serving several dozen patients with gastroparesis. Motion Sickness NDA: Vanda expects to submit an NDA for tradipitant for the treatment of motion sickness to the FDA in the fourth quarter of 2024. The NDA for the treatment of motion sickness is expected to include the positive results of three placebo controlled clinical studies where tradipitant was effective in preventing vomiting associated with motion. Vanda plans to initiate a clinical trial to study tradipitant in the prevention of vomiting induced by a GLP-1 analog (semaglutide) in the fourth quarter of 2024. Early-Stage Programs Vanda plans to proceed with studies of VSJ-110, a CFTR activator, for the treatment of dry eye disorder. An ongoing proof of concept study indicates an effect in improving the signs (fluorescein corneal staining) of dry eye disease. VPO-227, a CFTR inhibitor for the treatment of cholera, has received approval to proceed in a Phase I study in Bangladesh, a country where the treatment of cholera remains a significant and unmet need. Vanda plans to initiate this study by the end of 2024. The Phase I clinical study for VCA-894A for the treatment of a patient with Charcot-Marie-Tooth disease, axonal, type 2S (CMT2S), an inherited peripheral neuropathy for which there is no available treatment, expects to enroll the patient by the end of 2024. The Phase I clinical study for VTR-297 for the treatment of onychomycosis, a fungal infection of the nail, was initiated in April 2024. The study is fully enrolled, and results are expected by the end of 2024. VQW-765, an alpha-7 nicotinic acetylcholine receptor partial agonist, is currently in clinical development for the treatment of acute performance anxiety in social situations. GAAP Financial Results Net loss was $5.3 million in the third quarter of 2024 compared to net income of $0.1 million in the third quarter of 2023. Diluted net loss per share was $0.09 in the third quarter of 2024 compared to diluted net income per share of $0.00 in the third quarter of 2023. Net loss was $14.0 million in the first nine months of 2024 compared to net income of $4.9 million in the first nine months of 2023. Diluted net loss per share was $0.24 in the first nine months of 2024 compared to diluted net income per share of $0.09 in the first nine months of 2023. 2024 Financial Guidance Vanda is updating its 2024 financial guidance and expects to achieve the following financial objectives in 2024: Conference Call Vanda has scheduled a conference call for today, Wednesday, November 6, 2024, at 4:30 PM ET. During the call, Vanda's management will discuss the third quarter 2024 financial results and other corporate activities. Investors can call 1-800-715-9871 (domestic) or 1-646-307-1963 (international) and use passcode number 2555000. A replay of the call will be available on Wednesday, November 6, 2024, beginning at 8:30 PM ET and will be accessible until Wednesday, November 13, 2024 at 11:59 PM ET. The replay call-in number is 1-800-770-2030 for domestic callers and 1-609-800-9909 for international callers. The passcode number is 2555000. The conference call will be broadcast simultaneously on Vanda's website, . Investors should click on the Investors tab and are advised to go to the website at least 15 minutes early to register, download, and install any necessary software or presentations. The call will also be archived on Vanda's website for a period of 30 days. References IQVIA Prescription Data Calhoun SL, Fernandez-Mendoza J, Vgontzas AN, Liao D, Bixler EO. Prevalence of insomnia symptoms in a general population sample of young children and preadolescents: gender effects. Sleep Med. 2014 Jan;15(1):91-5. doi: 10.1016/j.sleep.2013.08.787. Epub 2013 Oct 16. PMID: 24333223; PMCID: PMC3912735. Fricke-Oerkermann L, Plück J, Schredl M, Heinz K, Mitschke A, Wiater A, Lehmkuhl G. Prevalence and course of sleep problems in childhood. Sleep. 2007 Oct;30(10):1371-7. doi: 10.1093/sleep/30.10.1371. PMID: 17969471; PMCID: PMC2266270. About Vanda Pharmaceuticals Inc. Vanda is a leading global biopharmaceutical company focused on the development and commercialization of innovative therapies to address high unmet medical needs and improve the lives of patients. For more on Vanda Pharmaceuticals Inc., please visit and follow us on X @vandapharma. CAUTIONARY NOTE REGARDING FORWARD LOOKING STATEMENTS Various statements in this press release, including, but not limited to, the guidance provided under "2024 Financial Guidance" above, and statements regarding Vanda's plans to strengthen and grow its business and diversify its sources of revenue; Vanda's plans for pursuit of FDA approval of milsaperidone for the treatments of schizophrenia and acute bipolar I disorder, tradipitant for the treatments of motion sickness and gastroparesis, and HETLIOZ® for the treatments of jet lag disorder and insomnia; European Medicines Agency action on the Marketing Authorization Application for HETLIOZ® and HETLIOZ LQ® for Smith-Magenis Syndrome; Vanda's clinical development plans for milsaperidone for the treatment of MDD, the LAI formulation of Fanapt®, PONVORY® for the treatments of psoriasis and ulcerative colitis, tradipitant for the prevention of vomiting induced by a GLP-1 analog, VSJ-110 for the treatment of dry eye, VPO-227 for the treatment of cholera, VCA-894A for the treatment of CMT2S, VTR-297 for the treatment of onychomycosis and VQW-765 for the treatment of acute performance anxiety in social situations; the initial market response to the commercial launch of Fanapt® for the acute treatment of bipolar I in adults; the prevalence of pediatric sleep disorders; the regulatory status of Vanda's Marketing Authorization Application for HETLIOZ® and HETLIOZ LQ® for SMS in Europe and its NDA for tradipitant for the treatment of symptoms of gastroparesis in the U.S.; and Vanda's plans to continue to support the tradipitant expanded access program for gastroparesis patients are "forward-looking statements" under the securities laws. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. Forward-looking statements are based upon current expectations and assumptions that involve risks, changes in circumstances and uncertainties. Important factors that could cause actual results to differ materially from those reflected in Vanda's forward-looking statements include, among others, Vanda's ability to correct the deficiencies identified by the FDA in the CRL with respect to the NDA for tradipitant for the treatment of symptoms of gastroparesis; Vanda's ability to complete and submit to the FDA the NDAs for tradipitant for the treatment of motion sickness and milsaperidone for the treatments of schizophrenia and acute bipolar I disorder within the specified timeframes; the FDA's assessment of the sufficiency of the data packages to be included in the NDAs for tradipitant and milsaperidone; Vanda's ability to correct the deficiencies identified by the FDA in the Complete Response Letter (CRL) with respect to the sNDA for HETLIOZ® for the treatment of insomnia; the outcome in the U.S. Court of Appeals of Vanda's challenge to the FDA's rejection of its sNDA for HETLIOZ® for the treatment of jet lag disorder; the accuracy of the lead indicators regarding the initial market response to the commercial launch of Fanapt® for the acute treatment of bipolar I disorder in adults; Vanda's ability to initiate the Phase III programs for milsaperidone for MDD and the LAI formulation of Fanapt® by the end of 2024; the accuracy of the estimates regarding the prevalence of pediatric sleep disorders; Vanda's ability to file the INDs for PONVORY® for the treatments of psoriasis and ulcerative colitis by the end of 2024; Vanda's ability to initiate the Phase I study for VPO-227 for the treatment of cholera by the end of 2024; Vanda's ability to enroll the patient for the Phase I study for VCA-894A for the treatment of CMT2S by the end of 2024; and Vanda's ability to complete the Phase I study of VTR-297 for the treatment of onychomycosis by the end of 2024. Therefore, no assurance can be given that the results or developments anticipated by Vanda will be realized or, even if substantially realized, that they will have the expected consequences to, or effects on, Vanda. Forward-looking statements in this press release should be evaluated together with the various risks and uncertainties that affect Vanda's business and market, particularly those identified in the "Cautionary Note Regarding Forward-Looking Statements", "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of Vanda's most recent Annual Report on Form 10-K, as updated by Vanda's subsequent Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the U.S. Securities and Exchange Commission, which are available at . All written and verbal forward-looking statements attributable to Vanda or any person acting on its behalf are expressly qualified in their entirety by the cautionary statements contained or referred to herein. Vanda cautions investors not to rely too heavily on the forward-looking statements Vanda makes or that are made on its behalf. The information in this press release is provided only as of the date of this press release, and Vanda undertakes no obligation, and specifically declines any obligation, to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. Corporate Contact: Kevin Moran Senior Vice President, Chief Financial Officer and Treasurer Vanda Pharmaceuticals Inc. 202-734-3400 [email protected] Jim Golden / Jack Kelleher / Dan Moore Collected Strategies [email protected] SOURCE Vanda Pharmaceuticals Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 1Drug ApprovalFinancial StatementNDAAcquisition

15 Oct 2024

·www.biospace.com

Vanda Rejects Another Acquisition Offer From Cycle, Affirms Confidence in Business

iStock, Atstock Productions Cycle’s second unsuccessful takeover bid comes on the heels of the FDA denying approval for Vanda’s tradipitant, which was being proposed for the treatment of gastroparesis. Vanda Pharmaceuticals on Monday announced that it has rejected a second unsolicited and non-binding takeover proposal from Cycle Pharmaceuticals. The proposed buyout price of $8.00 per share “substantially undervalues Vanda and is not in the best interests of the company and its stockholders,” according to Monday’s announcement. Vanda’s board of directors called the latest takeover attempt from Cycle an “opportunistic attempt to purchase the company’s shares at a discount to Vanda’s intrinsic value.” Vanda’s leadership said it remains “confident” in the company’s growth—driven by a strong cash position and efficient operations—which puts the biopharma in a good position to deliver long-term value “far in excess” of Cycle’s offer. There is no action required for stockholders at this time, according to the announcement. Cycle in its press release on the offer encouraged Vanda shareholders to express their support for the proposal, insisting that the $8.00-per-share price tag “represents [an] 80% premium to Vanda’s share price at the close of business on October 11, 2024.” At this purchase price, Cycle’s offer amounted to a fully diluted equity value of $488 million. Cycle’s latest takeover bid, which it filed on Sept. 23, comes just days after the FDA rejected Vanda’s drug application for the investigational NK-1R antagonist tradipitant, which it was proposing for the treatment of gastroparesis. While some analysts have called the rejection “unsurprising”—given a failed Phase III trial and amid unaddressed prior concerns from the FDA—Vanda has continued to strongly stand by its drug candidate, even going so far as to challenge the regulator’s verdict. The biopharma blasted what it called the “delayed” verdict of the FDA, claiming the regulator “fails to satisfy the requirements specified by the Food Drug and Cosmetic Act (FDCA).” Despite the rejection, Vanda will continue to seek approval for tradipitant and sustain its expanded access program. Cycle previously attempted to acquire Vanda in June 2024, for which it similarly offered $8.00 per share. At the time, the proposal reflected a 63% premium to Vanda’s closing price on May 23, 2024, the day before the offer was submitted. Vanda was also locked in a regulatory row with the FDA when it received Cylce’s first offer—this time over its oral drug Hetlioz (tasimelteon), which the agency rejected for the treatment of insomnia. As in the case of tradipitant, Vanda slammed the FDA’s rejection insisting that it was late in releasing its verdict in violation of the FDCA.

AcquisitionPhase 3

24 Sep 2024

·www.globenewswire.com

Busy Philipps Encourages Women to Take Charge of Their ADHD This Fall in Ongoing Collaboration with Supernus Pharmaceuticals and Qelbree

Ahead of ADHD Awareness Month, Busy is sharing her ADHD diagnosis and Qelbree® (viloxazine extended-release capsules) treatment story to empower women living with ADHD to advocate for their care.ADHD often presents differently in women than in men, which can make it more challenging to recognize in women and ultimately leaving them undiagnosed and untreated.1 ROCKVILLE, Md., Sept. 24, 2024 (GLOBE NEWSWIRE) -- In a continued collaboration with Supernus Pharmaceuticals, actress, author, podcaster, late-night host, and mom, Busy Philipps, is speaking up this fall about her ongoing journey with attention-deficit/hyperactivity disorder (ADHD), bringing awareness to the often-overlooked symptoms of the condition in women and Qelbree, a non-stimulant ADHD treatment that has benefitted her. With summer over and the school year now in full swing, the fall season brings for many adults a return to normal routines or schedules, as well as an opportunity for a fresh start. Busy knows first-hand just how difficult getting ‘back to schedule’ can be for the approximately 10 million adults living with ADHD, who may be experiencing symptoms of inattention, hyperactivity/impulsivity, or both.2 She’s sharing her story to help empower people, and especially women, living with ADHD to take action for a fresh start this fall and talk to their doctors about treatment options to help manage their condition. “For many years living with unmanaged ADHD, I’d often start a task and never remember to finish, frequently feeling restless and unable to stay still. I would ramble on, get easily distracted and have trouble multitasking, and with my busy lifestyle, it was a challenge,” says Busy. “Now that I’m taking Qelbree, I’m relieved that my ADHD symptoms are more manageable. I only wish I’d taken charge of my ADHD sooner. That’s why I’m sharing my story to raise awareness about ADHD and help others who may be struggling with their diagnosis find a treatment option that works for them like Qelbree has worked for me.” Qelbree is a novel, once-a-day, non-stimulant approach for patients 6 years and older with ADHD, and the first non-stimulant approved for adults with ADHD in 20 years. As a non-stimulant, Qelbree has no evidence of abuse or misuse and can be conveniently refilled without needing a new prescription each month. “As a leader in treating ADHD, Supernus is committed to providing treatment options and education to help people living with ADHD like Busy Philipps manage their ADHD symptoms,” says Jack A. Khattar, President and Chief Executive Officer of Supernus Pharmaceuticals. “We appreciate Busy’s continued support and willingness to share her ADHD story and experience with Qelbree, especially leading into ADHD Awareness Month.” 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. INDICATION Qelbree® (viloxazine extended-release capsules) is a prescription medicine used to treat ADHD in adults and children 6 years and older. IMPORTANT SAFETY INFORMATION Qelbree 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. 1Holthe, M. E. G., Langvik, E. (2017). The Strives, Struggles, and Successes of Women Diagnosed with ADHD as Adults. SAGE Journals. 2Culpepper, 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. 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, and dyskinesia in PD patients receiving levodopa-based therapy. 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 CEO Timothy C. Dec, Senior Vice President and CFO Supernus Pharmaceuticals, Inc. Tel: (301) 838-2591 Or INVESTOR CONTACT: Peter Vozzo ICR Westwicke Office: (443) 213-0505 Email: Peter.Vozzo@westwicke.com MEDIA CONTACT: Matthew FrappierTel: (646) 358-9683Email: Matthew.Frappier@bcw-global.com

Drug Approval

100 Deals associated with Tasimelteon

External Link

KEGG	Wiki	ATC	Drug Bank
D09388	Tasimelteon	N05CH03	DB09071

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Sleep Initiation and Maintenance Disorders	US	Vanda Pharmaceuticals, Inc.	01 Dec 2020
Sleep Wake Disorders	US	Vanda Pharmaceuticals, Inc.	31 Jan 2014

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Jet Lag Syndrome	NDA/BLA	US	Vanda Pharmaceuticals, Inc.	-
Autism Spectrum Disorder	Phase 3	US	Vanda Pharmaceuticals, Inc.	28 Jul 2021
Sleep Deprivation	Phase 3	US	Vanda Pharmaceuticals, Inc.	01 Sep 2015
Smith-Magenis Syndrome	Phase 3	US	Vanda Pharmaceuticals, Inc.	01 Sep 2015
Depressive Disorder, Major	Phase 3	US	Vanda Pharmaceuticals, Inc.	01 Sep 2011
Sleep Disorders, Circadian Rhythm	Phase 3	US	Vanda Pharmaceuticals, Inc.	01 Aug 2010
Sleep Disorders, Circadian Rhythm	Phase 3	DE	Vanda Pharmaceuticals, Inc.	01 Aug 2010
Pervasive child development disorders	Phase 2	US	Vanda Pharmaceuticals, Inc.	16 Sep 2021
REM Sleep Behavior Disorder	Phase 1	US	Vanda Pharmaceuticals, Inc.	30 Sep 2023
Sleepiness	Phase 1	CA	Vanda Pharmaceuticals, Inc.	01 Apr 2012

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03373201 (JET8 Study, CTgov)	Phase 3	Jet Lag Syndrome	320	Placebo (Placebo)	kiovpftpuj(eylxlnenss) = aqdeebhitj xlcbkoyyfe (ucmnqjbcjo, avrqydeklr - aybhbjhhsi) View more	-	15 Sep 2023
				Tasimelteon (Tasimelteon)	kiovpftpuj(eylxlnenss) = vgycfgoskn xlcbkoyyfe (ucmnqjbcjo, qkxbnuahxn - ikmgbbfxbj) View more
NCT03291041 (JET, Pubmed) Manual	Phase 2	Jet Lag Syndrome	25	tasimelteon	qqqjukhblv(kxlhbdfhqv): difference = 131	Positive	15 Sep 2022
				Placebo
NCT03291041 (JET, CTgov)	Phase 2	Jet Lag Syndrome	25	Tasimelteon (Tasimelteon)	tengvypnry(edztlvymua) = gcpmcysbvn dklahgnjke (lagujffxvq, mrxfddlugw - qlugjfnbqp) View more	-	03 Nov 2021
				Placebo (Placebo)	tengvypnry(edztlvymua) = trtuwyyqdp dklahgnjke (lagujffxvq, vxgoraftqx - yunevdbxht) View more
JET8 (WSC2019)	Not Applicable	-	318	Tasimelteon	qsatmxdvcf(ywupskhcfx) = vhdtfkpmny mxfodhduoj (bfgpbvbjpz )	Positive	20 Sep 2019
Magellan study (tasimelteon in MDD study) (WSC2017)	Not Applicable	Depressive Disorder, Major	507	Tasimelteon 20 mg	wnfufrrfqk(xiajxythne) = trcnsygbcn cchmykcldm (gqdxxrpubd ) View more	Positive	07 Oct 2017
				Placebo	wnfufrrfqk(xiajxythne) = hzgyxanigx cchmykcldm (gqdxxrpubd ) View more
NCT01163032 (SET, Pubmed \| Lancet) Manual	Phase 3	Sleep Disorders, Circadian Rhythm	84	tasimelteon	vbpakozuse(kfccgmszka) = wlescwmptp anyrwcfcer (hupwxncrnj ) View more	Positive	31 Oct 2015
				Placebo	vbpakozuse(kfccgmszka) = xqomrviwea anyrwcfcer (hupwxncrnj ) View more
NCT01428661 (MAGELLAN, CTgov)	Phase 2/3	Depressive Disorder, Major	507	tasimelteon (Tasimelteon)	dhggangmjt(japfwpjpte) = lrkokdlzuh ebziyuulzn (vinjvvingv, lheiqeumtf - ybwzlkadpk) View more	-	19 Jun 2015
				placebo (Placebo)	dhggangmjt(japfwpjpte) = ohjshxcwkb ebziyuulzn (vinjvvingv, omnbwhzvzs - vrambmjyji) View more
NCT01163032 (SET, CTgov)	Phase 3	Sleep Disorders, Circadian Rhythm	136	tasimelteon (Tasimelteon (Randomized))	jkjumezlgo(fcquiugumk) = pneilvqwlj jnbwlrhklt (sgnnzbwmmt, uqcvfdtjsh - iazbcbzjco) View more	-	16 Oct 2014
				Placebo (Placebo (Randomized))	jkjumezlgo(fcquiugumk) = ocbvyxtjuq jnbwlrhklt (sgnnzbwmmt, edqgxpfvod - ydrwjbdfsl) View more
NCT00291187 (CTgov)	Phase 3	Sleep Initiation and Maintenance Disorders	411	Placebo	xtqxopoknx(jiuaxasoue) = gnjkobkzgr wkwpvhicek (wvhxssqcek, hjscmzqtkl - tlblaljjoa) View more	-	15 Oct 2014
NCT01430754 (RESET, CTgov)	Phase 3	Sleep Disorders, Circadian Rhythm	20	tasimelteon (Tasimelteon)	svriimbhfm(vvglanwdev) = trryptvwny owqbilaxes (uhtbjbkkqx, vybjdjflfe - twkdkgmerq) View more	-	10 Oct 2014
				Placebo (Placebo)	svriimbhfm(vvglanwdev) = qgdhgcduse owqbilaxes (uhtbjbkkqx, gjbtyriywo - vkoibuyhzl) View more

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