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Last update 31 May 2025

Hydrocodone bitartrate

Last update 31 May 2025

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

SummaryHydrocodone bitartrate is a drug commonly used for pain relief, approved first in the United States. The drug works by binding to opioid receptors in the brain, acting as a mu/kappa/delta agonist. Its chemical name is 4,5(alpha)-epoxy-3-methoxy-17-methylmorphinan-6-one tartrate (1:1) hydrate (2:5) or morphinan-6-one, 4,5-epoxy-3-methoxy-17-methyl-, (5 alpha)-, [R (R*, R*)]-2,3-dihydroxybutanedioate (1:1),hydrate (2:5). Hydrocodone bitartrate is widely used in the U.S. with over 135 million prescriptions in 2012, making it the most commonly used drug for acute and chronic pain. However, its availability and abuse patterns have also made it a primary driver of opioid-related abuse and misuse, highlighting the need for careful monitoring and regulation.

Drug Type

Small molecule drug

Synonyms

酒石酸氢可酮, AFI-001, ATLP-03

+ [10]

Target

Opioid receptors

Action

agonists

Mechanism

Opioid receptors agonists(Opioid receptors agonists)

Therapeutic Areas

Nervous System DiseasesOther Diseases

Active Indication

Pain

Inactive Indication

Chronic osteoarthritisChronic PainKidney Failure, Chronic+ [3]

Originator Organization-

Active Organization

Purdue Pharma LP

Inactive Organization

Teva Branded Pharmaceutical Products R&D, Inc.

Societal CDMO Gainesville LLC

Zogenix, Inc.

+ [1]

License Organization-

Drug Highest PhaseApproved

First Approval Date

United States (25 Oct 2013),

Pain

Regulation-

Structure/Sequence

Molecular FormulaC22H29NO10

InChIKeyZICRJLQTAUVSDU-NSJZFRMTSA-N

CAS Registry34195-34-1

Clinical Trials associated with Hydrocodone bitartrate

NCT06780202

/ RecruitingPhase 2IIT

Assessment of Medrol Dosepak to Reduce Opioid Consumption in Foot and Ankle Surgical Patients

This clinical trial aims to determine the effects of a 6-day low-dose methylprednisolone course on pain, nausea, and total opioid consumption in patients undergoing foot and ankle surgeries.
The secondary objective of the study is to determine and monitor the effects of the course on complications following surgery and patient-reported outcomes

Start Date27 Jan 2025

Sponsor / Collaborator

Emory University

NCT06585163

/ Not yet recruitingPhase 1

A Phase 1, Randomized, Double-blind, Crossover Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of QEV-817 Oral Suspension in Healthy Volunteers

This study has been designed to assess the safety, tolerability, and pharmacokinetics of a therapeutic dose of hydrocodone bitartrate with and without an oral dose of doxapram hydrochloride in healthy volunteers who are naltrexone-blocked.

Start Date01 Sep 2024

Sponsor / Collaborator

Quivive Pharma, Inc.

[+1]

NCT06232577

/ Active, not recruitingPhase 2IIT

5x-Multiplier vs 3-Tier Model for Discharge Opioid Prescriptions After Intra-abdominal Cancer Surgery: A Randomized Clinical Trial

To compare 2 different models for prescribing opioid pain medication to provide better pain control to participants with an abdominal cancer who are having surgery.

Start Date27 Mar 2024

Sponsor / Collaborator

The University of Texas MD Anderson Cancer Center

100 Clinical Results associated with Hydrocodone bitartrate

100 Translational Medicine associated with Hydrocodone bitartrate

100 Patents (Medical) associated with Hydrocodone bitartrate

1,488

Literatures (Medical) associated with Hydrocodone bitartrate

01 Jul 2025·PHYTOMEDICINE

Integrated network pharmacology, metabolomics, and microbiome studies to reveal the therapeutic effects of Anacyclus pyrethrum in PD–MCI mice

Article

Author: Shataer, Munire ; Chen, Yan ; Yang, Xin Ling ; Tuersong, Tayier ; Yong, Yu Xuan ; Wu, Qin Fen ; Shataer, Samire ; Ma, Liang Ying ; Shan Li, Pei

BACKGROUND:

Anacyclus pyrethrum (l.) DC has potential value in treating Parkinson's disease (PD)-mild cognitive impairment (MCI), manifesting as impaired memory, attention, executive function, and language. However, the specific targets and modes of action of A. pyrethrum remain unclear.

PURPOSE:

The aim of this study was to identify the active components of A. pyrethrum and examine their effectiveness in treating a mouse model of PD-MCI.

METHODS:

We generated ethanol extracts of A. pyrethrum root (EEAP) and identified its active components and related targets using UHPLC-MS/MS and network pharmacology.The PD-MCI model was induced via intraperitoneal administration of 1-methyl-4-phenyl-1,2,3,6-tetrahydropyridine(MPTP). After following continuous administration of EEAP,Altered learning or memory, as well as anxiety, were tested using the morris water maze, eight-arm radial arm maze (RAM), and open-field test,elevated plus-maze. Brain histopathology and ultrastructural changes were examined using brightfield microscopy, and electron microscopy, respectively. Furthermore, protein expression was assessed using western blotting.Stool samples were used for metabolomics analysis by UHPLC-MS/MS and for 16S rDNA sequencing to determine the compositional changes of the gut microbiota.We conducted a short-chain fatty acid targeted metabolomics experiment to study their role in the gut-brain axis in PD-MCI.

RESULTS:

Using UPLC-MS-MS, 126 compounds were identified from A. pyrethrum samples.After searching the databases and literature reports, 31 active components and 544 drug-disease targets were screened. Biological processes and molecular functions, such as energy channels, cell signaling, and metabolism, were discovered through GO analysis. The water maze experiment showed that the average swimming distance and escape latency of mice in EEAP groups decreased. The eight-arm maze experiment showed that model had a much higher number of errors related to working memory than the control mice. In the open field experiment, compared with the control group, the mice in the EEAP group exhibited an increase in the average movement speed and total movement distance, along with a decrease in the residence time.In the elevated plus maze, the control had less anxiety than the Model. Donepezil/Levodopa(D/l) mitigated anxiety-like behavior, and EEAP (100-400 mg/kg) showed a dose-dependent increase in open-arm metrics, suggesting it may ease anxiety in mice.Hippocampal tissue of mice treated with different doses of EEAP showed intact cellular layers and the hematoxylin-eosin-stained cones were slightly better;cells were arranged neatly; their morphology was normal, and were distributed uniformly. Electron microscopy revealed that the nuclear membrane, chromatin, and nucleoli were clearly demarcated in the hippocampus of mice treated with different doses of EEAP, contrary to that in the model group. In brain extracts of the EEAP group, lighter thinner bands for amyloid precursor protein (APP) and Aβ were observed compared to those in the model group. In model mice, APP and Aβ protein expression was higher than in the blank group, as shown by stronger bands. In EEAP-treated mice, the bands were weaker, indicating reduced expression. In the model group had lower Bcl-2 and higher Bax levels. EEAP treatment increased Bcl-2 and decreased Bax expression.Compared to the control group, the model showed substantially low glutathione peroxidase (GSH-Px),superoxide dismutase(SOD),catalase (CAT)activity (p < 0.05),much higher (p < 0.05) in the EEAP-H group than that in the model. EEAP intervention significantly modulated the fecal metabolic profile of PD-MCI mice. The abundance of steroid and lipid metabolites, including linoleylethanolamine, was markedly altered in the model group compared to the control group, with EEAP treatment reversing several of these abnormalities. PLS-DA and OPLS-DA revealed significant separation between groups (Q2= 0.542, p < 0.01), confirming a dose-dependent effect. Random forest analysis identified 15 key metabolic markers, such as dose-dependent changes in d-glutamine and hydrocodone. Metabolic pathway analysis demonstrated significant enrichment in phenylalanine, tyrosine, tryptophan metabolism, and arginine biosynthesis pathways (p < 0.05). The Support Vector Machine (SVM) model achieved an AUC approaching 1, indicating substantial differences in metabolite profiles. EEAP intervention significantly influenced the composition and functional profile of the intestinal microbiota. The Venn diagram illustrates that each group shared 342 operational taxonomic units (OTUs), with the EEAP 400 group exhibiting a distinct Bacteroidetes proportion. LEfSe analysis identified g_Prevotella as the characteristic bacterium in the control group, c_Epsilonproteobacteria in the model group, and g_Adlercreutzia in the EEAP 100 group. The Faith's Phylogenetic Diversity (PD) index was highest in the EEAP 100 group, and Non-metric Multidimensional Scaling (NMDS)/Principal Coordinates Analysis (PCoA) revealed significant differences in microbial community structure. Short-chain fatty acids (SCFAs) analysis indicated that acetic acid was the predominant metabolite, while EEAP dose-dependently regulated propionic acid and isovaleric acid levels (VIP > 1, p < 0.001). These findings demonstrate that EEAP exerts its regulatory effects by reshaping the structure and metabolic functions of the gut microbiota.

CONCLUSION:

EEAP holds great promise as a potential therapeutic agent for PD-MCI, exerting its effects through multiple mechanisms, including regulating protein expression, modulating the fecal metabolic profile, and reshaping the gut microbiota and its metabolites.

01 Jun 2025·ANESTHESIOLOGY

Suzetrigine, a Nonopioid NaV1.8 Inhibitor for Treatment of Moderate-to-severe Acute Pain: Two Phase 3 Randomized Clinical Trials

Article

Author: Weiner, Scott G. ; Negulescu, Paul ; Solanki, Daneshvari ; D’Aunno, Dominick ; Miao, Xiaopeng ; Swisher, Matthew W. ; Correll, Darin J. ; McCoun, Jessica ; Tian, Simon ; Oswald, Jessica ; Urban, Joshua ; Bozic, Carmen ; Bertoch, Todd ; Taber, Louise

Background::

Opioids are effective for treating acute pain but have safety, tolerability, and addiction concerns while nonopioid analgesics have limited efficacy. Suzetrigine, an oral, nonopioid small molecule, selectively inhibits the voltage-gated sodium channel 1.8 (NaV1.8) and has potential to provide efficacious and safe relief for acute pain without addiction concerns.

Methods::

To evaluate suzetrigine for treatment of acute pain, two phase 3, randomized, double-blind, placebo- and active-controlled trials were conducted in adults with moderate-to-severe acute pain on the verbal categorical rating scale and 4 or greater on the numeric pain rating scale after abdominoplasty (n = 1,118) or bunionectomy (n = 1,073). After surgery, participants were randomized to suzetrigine (100 mg, then 50 mg every 12 h), hydrocodone bitartrate/acetaminophen (5/325 mg every 6 h), or placebo for 48 h. The primary endpoint was time-weighted sum of the pain intensity difference in numeric pain rating scale from 0 to 48 h (SPID48) versus placebo. Key secondary endpoints were SPID48 versus hydrocodone bitartrate/acetaminophen and time to 2-point or greater reduction in numeric pain rating scale from baseline versus placebo.

Results::

The primary endpoint was achieved in both trials with suzetrigine demonstrating statistically significant and clinically meaningful reduction in pain versus placebo. The least squares mean difference in SPID48 between suzetrigine and placebo was 48.4 (95% CI, 33.6 to 63.1; P < 0.0001) after abdominoplasty and 29.3 (95% CI, 14.0 to 44.6; P = 0.0002) after bunionectomy. Neither trial achieved the first key secondary endpoint of superiority of suzetrigine versus hydrocodone bitartrate/acetaminophen on SPID48. For the second key secondary endpoint of time to 2-point or greater reduction in numeric pain rating scale, suzetrigine had a more rapid onset of clinically meaningful pain relief versus placebo after abdominoplasty (119 min vs. 480 min; nominal P < 0.0001) and bunionectomy (240 min vs. 480 min; nominal P = 0.0016). Adverse events were similar to those seen in postsurgical settings.

Conclusions::

As compared with placebo, suzetrigine reduced moderate-to-severe acute pain over 48 h after abdominoplasty or bunionectomy. Pain reduction with suzetrigine was similar to that with hydrocodone bitartrate/acetaminophen. Suzetrigine was associated with adverse events that were mild to moderate in severity.

01 Jun 2025·LARYNGOSCOPE

Are More Adults Bleeding After Tonsillectomy Than in the Past?

Article

Author: Varavenkataraman, Gaayathri ; Carr, Michele M. ; Cottone, Chloe ; Marcus, Chennai A. ; Erwin, Dylan Z. ; Raghavan, Maya ; Akella, Deepthi

Objective:

Post‐tonsillectomy hemorrhage (PTH) rates have increased in children over the last decade. This study aimed to determine whether PTH incidence in adults had also increased over the last 15 years.

Study Design:

Retrospective study.

Setting:

TriNetX database.

Methods:

A search was conducted using TriNetX for patients 18 years and older within the US Collaborative Network who had undergone tonsillectomy (CPT codes 42821 or 42826) and yielded 72,232 subjects. PTH diagnoses were identified using ICD‐10 codes J95.830 or K91.840, and those who returned to the operating room (RTOR) to control PTH were identified using CPT 42962. PTH events that occurred and analgesics given following 14 days of tonsillectomy were tabulated annually from 2008 to 2022. Mann‐Kendall test for monotonic trend examined significant trends in PTH and analgesic use.

Results:

Mean age at tonsillectomy was 32.8 years (SD = 13.8). 4.1% were diagnosed with PTH in 2008, compared with 6.2% by 2022 (p = 0.0030). In 2008, 0.7% required RTOR to control PTH, compared with 2.4% in 2022 (p < 0.0001). Use of codeine decreased from 6.9% in 2008 to 2.5% in 2022 (p = 0.0022). Use of ibuprofen, acetaminophen, ketorolac, and oxycodone increased from 1.6% to 23.4% (p = 0.0005), 36.1% to 78.6% (p < 0.0001), 1.5% to 11.9% (p < 0.0001), and 20.6% to 63.6% (p < 0.0001), respectively. No change was detected in use of hydrocodone.

Conclusion:

Post‐tonsillectomy analgesia in adults has changed significantly over the last 15 years. Our study highlights a concurrent increase in PTH which bears more investigation.

Level of Evidence:

3 Laryngoscope, 135:1958–1963, 2025

News (Medical) associated with Hydrocodone bitartrate

08 May 2025

·www.biopharmadive.com

Viatris’ new form of old pain drug scores in large trials

Pittsburgh-based pharmaceutical firm Viatris on Thursday said a pain drug its been developing succeeded in two large clinical trials, setting the stage for an approval filing later this year.The drug is a reformulated version of an old medication, meloxicam, designed to more quickly treat the sharp, acute pain felt after an injury or operation. Researchers evaluated the drug in a dental pain study in 2022. Not long after, a pair of late-stage clinical trials began assessing it in nearly 1,000 people who had just undergone either a bunion removal or a hernia repair surgery.Results from those trials, according to Viatris, now show that pain scores improved substantially more for participants given the drug rather than a placebo. The main goal of both experiments revolved around a scoring system that measures pain intensity over a two-day period. Its the same system Vertex Pharmaceuticals used in the studies that ultimately led to the approval of Journavx, a closely watched, non-opioid pain reliever.Viatris, like Vertex, also set up arms in its trials to compare the relief provided by its drug to that of an opioid. The company said after-the-fact analyses found the drug offered significantly superior pain control to tramadol. The amount of time it took for participants to sense some pain reduction and to classify that reduction as meaningful was also comparable between the two groups and, in some cases, shorter for those on Viatris therapy.Journavx did not significantly outperform the opioid arms in Vertexs studies, though those used a combination of Tylenol and a more potent opioid, hydrocodone.Additionally, Viatris said that during the main treatment phase of its studies, there was a notable reduction in opioid usageas well as a higher number of opioid-free patients in the drug group as opposed to the placebo group. Patients also generally tolerated the drug well. There were few so-called severe treatment emergent adverse events, and the incidence of them was comparable across the two groups.All this evidence optimally positions Viatris drug to become a first-line treatment for moderate-to-severe acute pain, according to Philippe Martin, the companys research and development head. “The data observed ... is a critical step in the development of a safe and effective non-opioid option to address an important public health need, he said in a statement.The trial results were released alongside Viatris first quarter earnings report. The company, which officially formed in 2020, when Mylan merged with Pfizers Upjohn unit, recorded $3.3 billion between January and March, an 11% decrease from the same period a year prior. Viatris shares were up over 10% late Thursday morning, to trade around $9.48 apiece.Shares of Vertex, meanwhile, were down more than 2%, capping off a week in which the company lost tens of billions of dollars in value thanks, in part, to an earnings report that disappointed investors.Michael Yee, a Jefferies analyst who covers Vertex, wrote in a note to clients that first quarter revenue and earnings per share were light. But what stood out was the company saying Journavx revenue was “insignificant during the period, even though cumulative prescriptions had grown to around 25,000 by late April.Brian Skorney, a Baird analyst who also follows Vertex, wrote in his own note that the new Viatris data highlight a number of concerns we have with Journavxs profile, in particular, onset of action, a critical factor for post-operative pain.Skorney went on to suggest the respective bunionectomy studies make Journavx look like an inferior option compared to a pretty old albeit new and fast-acting non-steroidal anti-inflammatory drug, or NSAID.If NSAID's don't have the highest efficacy, as Vertex is fond of saying, what does that say about Journavx? he wrote. '

Financial StatementClinical Result

10 Apr 2025

·www.prnewswire.com

Newborn Brains Are Smaller When Exposed to Opioids During Gestation

An important "first dive" into data from the 4-site Outcomes of Babies with Opioid Exposure (OBOE) study features a Cincinnati Children's expert as co-first author CINCINNATI, April 10, 2025 /PRNewswire/ -- When pregnant women take opioids during pregnancy, even opioids such as buprenorphine or methadone to treat opioid use disorder, the developing brains of their children can be significantly affected, according to a study published April 7, 2025, in JAMA Pediatrics. Continue Reading Antenatal opioid exposure is associated with smaller neonatal brain volumes, with varying impact depending on the type and number of exposures, according to research published in JAMA Pediatrics. Stephanie Merhar, MD, MS, at Cincinnati Children's was first co-author. Total brain volume was nearly 5% smaller among 173 newborns with antenatal opioid exposure compared to 96 unexposed newborns, based on magnetic resonance imaging (MRI) scans. More specifically, reduced volumes among opioid-exposed newborns occurred in cortical gray matter, deep gray matter, white matter, cerebellum, brainstem, and the right and left amygdala. There were notable differences in the location and scale of the effects, which varied depending on the type of opioid involved, and whether other drugs were also taken during pregnancy. "We have known for a while that children exposed to opioids during pregnancy are at risk of later developmental and behavioral problems, but it was hard to know whether that was due to the opioids themselves or other factors such as other exposures or lower birth weight," says co-first author Stephanie Merhar, MD, MS, a neonatologist at Cincinnati Children's. "This study was launched because we needed a large study where we were able to control for things like nicotine exposure and birth weight. Our next step is to follow the children in the study to see whether having smaller brain volumes in the newborn period affects later development and behavior." The double-threat opioids pose to mothers and children Nearly 1 in 12 newborns in the United States in 2020 – or about 300,000 infants – were exposed to alcohol, opioids, marijuana or cocaine before they were born, according to the Substance Abuse and Mental Health Services Administration (SAMHSA). Prenatal substance exposure in rural areas often exceeds overall national averages. Opioids include illegal drugs like heroin and fentanyl, prescription drugs like oxycodone and hydrocodone, and medications for opioid use disorder like buprenorphine and methadone. Opioid use often goes hand in hand with smoking and use of other substances such as alcohol and marijuana. This study compared newborns born to mothers who took opioids only and newborns born to mothers who used other substances as well as opioids. Newborns exposed to opioids plus other substances had smaller brain volumes in more regions compared to those exposed to opioids only. The most common opioids among participants in the new study were buprenorphine (68.8%) and methadone (26%). Both of these opioids are routinely used to treat opioid use disorder (OUD) and are both recommended for treatment of OUD during pregnancy by the American College of Obstetricians and Gynecologists. "We know that buprenorphine and methadone are life-saving medications for women with OUD," Merhar says. "We don't want to imply that women with OUD should wean off these medications, but we agree with the ACOG recommendation for more research on medically supervised withdrawal in pregnant women." The study was praised in an accompanying editorial penned by Nethra Madurai, MD, and Lauren Jantzie, PhD, both of Johns Hopkins University School of Medicine. Other small studies have shown fetal brain changes caused by opioids. But this multi-center study is the first to be large enough to convincingly distinguish effects linked to opioids versus confounding factors such as maternal smoking, birth weight, education levels. The study authors "present compelling evidence of the direct effects of opioids on the developing brain," the editorial states. "Given the prospective design of the trial, they account for other postnatal factors…allowing us to dispel previous uncertainty surrounding the direct impacts of opioids on the brain vs the confounding effects of other environmental factors." What's next? Having more precise information about the affected parts of the brain could allow scientists to focus on interventions to support healthy brain development for children born after opioid exposure. "Indeed, we must shift our focus beyond the initial withdrawal symptoms associated with POE [prenatal opioid exposure] if we are to improve the lifelong health and well-being of infants and children impacted by the opioid epidemic," the editorial states. Read more about Merhar's research related to opioid exposure: 'Eat, Sleep, Console' Approach Slashes ICU Stays for Opioid-Exposed Newborns In Utero Opioid Exposure Impacts Fetal Brain Size and Development $8M Grant Funds Long-Term Opioid Exposure Study SOURCE Cincinnati Children's Hospital Medical Center WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

07 Apr 2025

·www.prnewswire.com

Elysium Therapeutics Announces Development of Overdose Rescue Technology Specifically Designed for Oral Fentanyl

Synthetic Opioid Overdose Prevention and Reversal (SOOPR™) targets an unmet challenge in the illicit opioid crisis as current rescue medications are not designed for synthetic opioids, including oral fentanyl. LYONS, Colo., April 7, 2025 /PRNewswire/ -- Elysium Therapeutics, an emerging biopharmaceutical company developing treatments specifically designed to rescue and reverse overdoses caused by oral opioids, including synthetic opioids like fentanyl, announced its plan to accelerate development of its Synthetic Opioid Overdose Prevention and Reversal (SOOPR™) technology. The company has completed in vivo proof-of-concept studies and expects to file an Investigational New Drug (IND) application in 2026. SOOPR is a rapid-onset, long-acting rescue agent specifically designed to address overdose from synthetic opioids, including oral fentanyl. SOOPR utilizes a proprietary long-acting naloxone prodrug formulation with faster onset kinetics versus Narcan® delivered via long-acting injection (LAI) technology. The technology is designed to rapidly restore respiration and provide 18 to 24 hours of effective opioid blockade to minimize the risk of re-narcotization, while also providing protection from same-day re-use of opioids. "Fentanyl overdoses often require very high, or repeated, doses of short-acting opioid antagonists to effect a successful rescue," said Greg Sturmer, Co-Founder and CEO of Elysium Therapeutics. "Unfortunately, many who overdose face a rapid recurrence of symptoms, known as re-narcotization, which can lead to respiratory depression and increase the likelihood of hypoxic brain injury or death. SOOPR is designed to address this situation, and Elysium is now focused on advancing its development as a potential first-ever, faster-onset, longer-acting opioid rescue therapy specifically intended to treat fentanyl overdose." Currently approved short-acting opioid antagonists like Narcan and Opvee® were designed to effectively counteract overdoses from opioids such as heroin and oxycodone. However, these rescue agents are frequently ineffective in the management of synthetic opioid overdoses1, with 20 to 45% of overdose victims initially rescued with naloxone experiencing a re-narcotization event. According to reports from multiple state-affiliated health agencies, 31 to 39% of fentanyl overdose decedents had been administered naloxone.2 Data from in vivo proof-of-concept studies of SOOPR demonstrated a more rapid onset of action versus naloxone (Narcan) and a significantly longer duration of action. This profile is especially useful in counteracting oral fentanyl overdoses associated with prolonged fentanyl absorption and exposure that often outlast the short-acting profile of Narcan. "In designing SOOPR, Elysium recognized that synthetic opioids – now the number one killer of adults aged 18 to 45 in the U.S. – are particularly lethal," said Tom Jenkins, Ph.D., Co-Founder and Chief Scientific Officer of Elysium Therapeutics. "Patients initially treated with a rapid-acting, long-duration reversal agent, such as SOOPR, are expected to have less risk of hypoxic brain injury, cardiovascular events, re-narcotization, and death. Further, rescue interventions with SOOPR are expected to require less intensive monitoring in both the ambulance and emergency department and increase the likelihood of survival. Additionally, SOOPR is designed to be delivered by intramuscular injection, either using a pre-filled syringe or autoinjector, which has been demonstrated to be more rapid and predictable than intranasal delivery in urgent settings, where every second counts." "In addition to preventing overdose deaths from recreational, illicit use, the Department of Defense (DOD) has made clear the importance of improving opioid overdose rescue as a needed medical countermeasure," added Sturmer. "The DOD reported that the availability of synthetic opioids, such as fentanyl and its derivatives, represents a significant threat as a chemical weapon, which could be easily disseminated as a weapon of mass destruction into air, water or food supplies, putting countless lives at risk. We look forward to working with defense and government organizations as we develop SOOPR as a tool to prevent injury and death in these worrisome scenarios." About SOOPR™ (Synthetic Opioid Overdose Prevention and Rescue) SOOPR (Synthetic Opioid Overdose Prevention and Reversal) is a rapid-onset, long-acting rescue agent specifically designed to address overdose from synthetic opioids, including oral fentanyl. SOOPR utilizes a proprietary long-acting naloxone reversal formulation with faster onset kinetics versus Narcan® delivered via long-acting injection (LAI) technology. The technology is designed to rapidly restore respiration and provide 18 – 24 hours of effective opioid blockade to minimize the risk of re-narcotization, while also providing protection from same-day re-use of opioids. SOOPR has been endorsed by first responders and OUD treatment professionals as the effective solution urgently needed to address the global opioid overdose epidemic. About Elysium Therapeutics Elysium is an emerging biopharmaceutical company developing treatments specifically designed to rescue and reverse overdoses caused by oral synthetic opioids, including fentanyl. Elysium is working to establish new standards of safety in the opioid industry by developing SMART™ (Safer Medicines Alleviate Risks and Trauma) products, first- and best-in-class medicines that address the limitations and dangers associated with opioids and overdose rescue agents to reduce suffering from opioid-use disorder, opioid overdose, and acute pain. Elysium's lead technology, SOOPR™ (Synthetic Opioid Overdose Prevention and Reversal), is a long-acting opioid antagonist specifically designed to address oral synthetic opioid, including fentanyl, overdose. Tens of thousands of unnecessary overdose deaths each year exemplifies the critical shortcomings of currently available rescue agents, including naloxone and nalmefene. In addition, Elysium is developing oral-overdose protected (O2P™) hydrocodone for the treatment of moderate-to-severe acute pain. For more information, please visit . 1 Rachael Rzasa Lynn and JL Galinkin Ther Adv Drug Saf 2018, Vol. 9(1) 63–88 (Also see footnotes 8, 9, and 10 for additional discussion). 2 Watson, W.A., Steele, M.T., Muelleman, R.L., Rush, M.D., 1998. Opioid toxicity recurrence after an initial response to naloxone. J. Toxicol. Clin. Toxicol. 36 (1-2), 11–17. . SOURCE Elysium Therapeutics WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Drug Approval

100 Deals associated with Hydrocodone bitartrate

External Link

KEGG	Wiki	ATC	Drug Bank
-	Hydrocodone bitartrate	R05DA03	-

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Pain	United States	Societal CDMO Gainesville LLC	25 Oct 2013

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Osteoarthritis	Phase 3	United States	Teva Branded Pharmaceutical Products R&D, Inc.	01 Nov 2010
Chronic Pain	Phase 3	United States	Zogenix, Inc.	01 May 2010
Low Back Pain	Phase 3	United States	Zogenix, Inc.	01 Mar 2010
Chronic osteoarthritis	Phase 2	-	Zogenix, Inc.	01 Sep 2002
Pain, Postoperative	Phase 2	-	Zogenix, Inc.	01 Aug 2002
Kidney Failure, Chronic	Phase 1	United States	Cephalon, Inc.	01 Mar 2011

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ACR2018	Not Applicable	-	-	Opioid (Total Hip Replacement (THR))	pwvoyzcbsk(xuvjnukqkl) = vhvzfvmwzv hkdpaokree (zbuomfetsu ) View more	-	22 Oct 2018
				Opioid (Total Knee Replacement (TKR))	pwvoyzcbsk(xuvjnukqkl) = icstsoyxvh hkdpaokree (zbuomfetsu ) View more
NCT01402375 (CTgov)	Phase 3	Analgesia \| Acute Pain	720	Hydrocodone (first trial) (Hydrocodone (First Trial))	uuanngfloc(vikricdjgl) = aivvqdpfwz afpheoqgqs (hyxcrggrul, 1.7) View more	-	01 May 2018
				Codeine (Codeine (First Trial))	uuanngfloc(vikricdjgl) = vmrfjvmiyp afpheoqgqs (hyxcrggrul, 1.8) View more
NCT01240863 (CTgov)	Phase 3	Low Back Pain \| Osteoarthritis \| Chronic Pain	391	Placebo (Placebo (Double-blind Treatment Period))	qfswaiwccq(xlpbwendsc) = sizwayqbbu rshujpghve (soxszsfaoj, 0.169) View more	-	05 Jun 2017
				Hydrocodone ER (Hydrocodone ER (Double-blind Treatment Period))	qfswaiwccq(xlpbwendsc) = jfgtvxcebi rshujpghve (soxszsfaoj, 0.176) View more
NCT01922739 (CTgov)	Phase 3	Low Back Pain	182	Placebo+Hydrocodone ER	ucnbpdwccr = xhcjykqucu olrhxxtjzk (zlbchhtxzq, vjtdhlfidb - lijsopkkib) View more	-	02 Jun 2017
NCT01789970 (CTgov)	Phase 3	Low Back Pain	625	Placebo (Placebo (Double-blind Treatment Period))	hyqsyraktz(nmcjcggkmp) = nahapyxhzd tqtlwcfjiv (sbxssuhuek, 0.145) View more	-	05 Apr 2017
				Hydrocodone ER (Hydrocodone ER (Double-blind Treatment Period))	hyqsyraktz(nmcjcggkmp) = ncfuibddjt tqtlwcfjiv (sbxssuhuek, 0.134) View more
NCT01517295 (CTgov)	Phase 4	Chronic Pain	30	Hydrocodone (Group 1)	lcpqzjandn(plevxjbfwc) = phnsnlmjmy xdxfmhjozs (jxsamvetcd, 0) View more	-	28 Jul 2016
				Hydrocodone (Group 2)	lcpqzjandn(plevxjbfwc) = rkotrltxtk xdxfmhjozs (jxsamvetcd, 0) View more
NCT01859715 (CTgov)	Not Applicable	Medication interactions	502	Oxycodone (Oxycodone Group)	atewmofxfj(npnlurxzlc) = gmneugtuak gnogvitmfo (esylkadgxq, qtuekaquvj - sgjitimbbb) View more	-	05 May 2016
				Hydrocodone (Hydrocodone/Acetaminophen Group)	atewmofxfj(npnlurxzlc) = eqmsjnmdry gnogvitmfo (esylkadgxq, bfkyrvuuyw - ylqxerztmx) View more
NCT01400139 (CTgov)	Phase 3	Chronic Pain	922	Hydrocodone bitartrate (HYD) (HYD Core Study)	havmhdgfvu = jffbhtnpha dzlrdhfabp (kymmcrwocx, vgmvzezjue - wnhcirjpiq) View more	-	04 Dec 2014
				Hydrocodone bitartrate (HYD) (HYD Extension Period)	havmhdgfvu = loopyybkcs dzlrdhfabp (kymmcrwocx, kcyhgciiqr - qubcjizemm) View more
NCT01452529 (CTgov)	Phase 3	Low Back Pain	905	Hydrocodone bitartrate (Hydrocodone Bitartrate)	qrbpgybbil(ompeilwtzv) = kmlprskycv jynyhrklat (nxqxnokhxn, 0.13) View more	-	04 Dec 2014
				Placebo to match hydrocodone bitartrate q24h tablets (Placebo)	qrbpgybbil(ompeilwtzv) = jmplwtnhpc jynyhrklat (nxqxnokhxn, 0.13) View more
NCT01115569 (CTgov)	Phase 3	Chronic Pain	424	Hydrocodone Bitartrate (Open-label Hydrocodone Bitartrate Extended Release Capsules)	ucytvblslj(zplniberjz) = icnpihmxse ldhyrmyvyi (wrfyrrsxcd, 2.2)	-	25 Apr 2014
				Hydrocodone Bitartrate (Conversion/Titration Phase)	ernsxmjbhs(zjtdliiaym) = yimqfxzbjf yqqmlawgky (ukdwuvaiir, ofnbyfzcso - olqfqhmpyr) View more

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