Delving into the Latest Updates on Hydrocodone bitartrate with Synapse

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

+ [9]

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 PainLow Back Pain+ [2]

Originator Organization-

Active Organization

Purdue Pharma LP

Inactive Organization

Teva Branded Pharmaceutical Products R&D LLC

Zogenix, Inc.

Cephalon, Inc.

+ [1]

License Organization-

Drug Highest PhaseApproved

First Approval Date

United States (25 Oct 2013),

Pain

Regulation-

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Structure/Sequence

Molecular FormulaC22H29NO10

InChIKeyZICRJLQTAUVSDU-NSJZFRMTSA-N

CAS Registry34195-34-1

There is limited knowledge regarding whether board-certified emergency medicine (EM) physicians have different opioid prescribing rates compared to other physicians working in emergency departments (EDs). This study aims to determine if opioid prescribing rates differ based on board-certification status compared with other physicians practicing in an ED setting.

Methods:

An IRB-approved, cross-sectional analysis was performed on the Medicare Part D Prescribers by Provider and Drug datasets from 2018 to 2020 to determine prescribing rates of EM physicians by board-certification status with the American Board of Emergency Medicine or the American Osteopathic Board of Emergency Medicine. EM physicians prescribing opioids to 11 or more Medicare beneficiaries per calendar year in EDs were included. The average total day supply (TDS) of opioids per beneficiary for the 4 most common opioids (acetaminophen/codeine, hydrocodone/acetaminophen, oxycodone/acetaminophen, tramadol) was estimated using generalized linear models with Poisson distribution, log-link, and individual clustering and compared by board certification in EM status. Incident rate ratios (IRR) were used to describe the association between board certification in EM and the average TDS of opioids.

Results:

A total of 29,144 physicians were included in the study, with 23,720 (81.4%) board-certified by the American Board of Emergency Medicine or the American Osteopathic Board of Emergency Medicine and 5424 (18.6%) certified by another specialty board (eg, family medicine [48.6%], internal medicine [17.3%]). Physicians working in EDs, who were not board-certified in EM, prescribed a higher average TDS compared with board-certified EM physicians: acetaminophen/codeine (TDS, 10.8 vs 4.0; IRR, 2.7 [95% CI, 2.3-3.2]); hydrocodone/acetaminophen (TDS, 15.2 vs 3.8; IRR, 4.0 [95% CI, 3.7-4.4]); oxycodone/acetaminophen (TDS, 19.8 vs 4.4; IRR, 4.5 [95% CI, 3.8-5.3]); tramadol (TDS, 20.1 vs 5.3; IRR, 3.8 [95% CI, 3.5-4.1]).

Conclusions:

Board certification in EM was associated with lower opioid prescribing rates. The average TDS of opioids per Medicare beneficiary was lower for board-certified EM physicians compared to non-EM board-certified physicians staffing EDs between 2018 and 2020.

01 Mar 2026·Journal of Plastic Reconstructive and Aesthetic Surgery

Trends in opioid prescribing by plastic surgeons for medicare part D patients

Article

Author: Soltani, Hannah ; Jagasia, Puja ; Ko, Jason H ; Nenchev, Kristian ; Howard, Michael A ; Teven, Chad M ; Allison, Sophia G ; Zhang, Jason

PURPOSE:

Previous analyses of Medicare part D opioid prescribing by plastic surgeons demonstrated decreasing prescription rates, but data in past 2017 have not been well-described. This study aims to elucidate more recent patterns in plastic surgery opioid prescribing.

METHODS:

Opioid prescriptions by plastic surgeons from 2013 to 2022 were retrospectively extracted from the CMS Medicare part D Prescribers database. Analyses were normalized to per million Medicare part D beneficiaries.

RESULTS:

From 2013 to 2022, 997,765 opioid prescriptions were extracted from the database. The top 2 opioids prescribed were hydrocodone (520,893; 52.2%) and oxycodone (307,206; 30.8%). The top 2 states by volume of opioid prescriptions were Mississippi (50,992 claims per million beneficiaries) and Georgia (48,911). The Southern region had the most opioid prescriptions (590,086 claims per million beneficiaries), while the Northeast had the least (120,671). The opioid prescribing rate decreased across the study period, from 3360 to 1554 prescriptions per million beneficiaries (53.8% decrease). The number of patients with an opioid prescription also decreased from 2211 per million beneficiaries in 2013 to 1272 in 2022 (42.5% decrease). Similarly, the total days supplied decreased from 24,608 days per million beneficiaries (2013) to 6824 (2022), a 72.3% decrease.

CONCLUSION:

Opioid prescribing for plastic surgery has declined from 2013 to 2022. Despite these promising trends, it is important to continue efforts to monitor and control opioid prescribing.

01 Feb 2026·JOURNAL OF HAND SURGERY-AMERICAN VOLUME

Perioperative Opioid Prescriptions in Patients on Oral Anticoagulants Undergoing Elective Soft Tissue Hand Surgery

Article

Author: Zhuang, Thompson ; Lee, Hannah H

PURPOSE:

Oral anticoagulation use is increasing in prevalence in the hand surgery population and poses a challenge for perioperative pain management, given the relative contraindication of nonsteroidal anti-inflammatory drug use. Anticoagulated patients may be prescribed opioids after hand surgery, leading to opioid use-related risks. In this study, we tested the hypothesis that preoperative oral anticoagulant use was associated with the incidence of perioperative opioid prescriptions in opioid-naive patients undergoing elective soft tissue hand surgery.

METHODS:

We identified opioid-naive adult patients undergoing carpal tunnel/trigger finger/DeQuervain release or hand/wrist mass excision using a national administrative claims database. Patients with preoperative oral anticoagulant prescriptions were propensity score-matched to those without. Oral anticoagulants were subdivided into direct oral anticoagulants (apixaban, rivaroxaban, dabigatran, and edoxaban) or warfarin. The primary outcome was the incidence of perioperative opioid prescriptions. The incidence of postoperative emergency department (ED) visits was measured as a secondary outcome. Multivariable logistic regression models were used to evaluate the association between perioperative opioid prescription and ED visits, adjusting for age, sex, region, insurance plan, and Elixhauser comorbidity index.

RESULTS:

After propensity score matching, patients with preoperative oral anticoagulant prescriptions were more likely to be prescribed perioperative opioids (odds ratio, 1.77 [1.60-1.96] for direct oral anticoagulants, odds ratio: 1.59 [1.42-1.77]) for warfarin. The most commonly prescribed opioids were hydrocodone with acetaminophen and tramadol. Being prescribed perioperative opioids was not associated with an increased incidence of postoperative ED visits.

CONCLUSIONS:

Preoperative oral anticoagulant use was associated with an increased incidence of perioperative opioid prescriptions in patients undergoing elective soft tissue hand surgery.

TYPE OF STUDY/LEVEL OF EVIDENCE:

Prognostic II.

52

News (Medical) associated with Hydrocodone bitartrate

28 Jan 2026

·www.prnewswire.com

Elysium Therapeutics Raises $7.5 Million SAFE Round to Accelerate Development of Novel Rescue Therapy Designed to Specifically Combat Oral Fentanyl Overdose

LYONS, Colo., Jan. 28, 2026 /PRNewswire/ -- Elysium Therapeutics, an emerging biopharmaceutical company developing treatments specifically designed to prevent and reverse overdoses caused by highly potent, synthetic opioids especially when ingested orally, today announced that it has completed a $7.5 million SAFE round. Elysium intends to accelerate development of its SOOPR™ (Synthetic Opioid Overdose Protection and Reversal) technology designed specifically as a rescue treatment for overdoses brought on by synthetic opioids, including fentanyl and the emerging threat of more potent nitazenes. "With these funds in place, we have initiated work to progress our SOOPR technology through preclinical and clinical studies as we develop this important, life-saving technology to address the deadly overdose epidemic caused by illicit synthetic opioids," said Greg Sturmer, CEO of Elysium Therapeutics. "Our society continues to see far too many overdose fatalities, and we believe that our SOOPR technology has enormous potential to become the new standard for rescue and as a countermeasure as the illicit drug market evolves to progressively more dangerous opioids." SOOPR is a rapid-onset, long-acting rescue agent specifically designed to prevent and reverse overdoses from synthetic opioids, including oral fentanyl and nitazenes. SOOPR utilizes a proprietary naloxone prodrug formulation that offers more rapid onset and longer duration of action than current rescue agents (e.g., NARCAN, Kloxxado, Opvee). The technology is designed to rapidly restore respiration, reducing the risk of hypoxic brain injury and death, and provide 12 – 24 hours of effective opioid blockade to minimize the risk of re-narcotization. Further, SOOPR delivers naloxone with a unique, infusion-like pharmacokinetic profile that is ideally suited to reduce the risk of severe withdrawal symptoms commonly associated with nalmefene and high-dose naloxone products. SOOPR is also intended to prevent same-day re-use of opioids and to offer an essential period for family members and healthcare professionals to assist the overdose patient in accessing medically-assisted therapy, which represents their best opportunity for long-term survival. Data from in vivo proof-of-concept studies of SOOPR demonstrated a more rapid onset of action versus intranasal and intramuscular naloxone and a significantly longer duration of action. This profile is specifically designed to counteract oral fentanyl and nitazene overdoses associated with prolonged exposures that often outlast the short-acting profile of existing rescue agents. 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 and nitazenes. 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 fast-onset, long-acting opioid antagonist specifically designed to address oral synthetic opioid overdose. Tens of thousands of unnecessary overdose deaths each year exemplifies the critical shortcomings of currently available rescue agents, including NARCAN and Opvee. In addition, Elysium is also developing oral-overdose protected (O2P™) hydrocodone for the treatment of moderate-to-severe acute pain, having achieved human proof-of-concept demonstrating a significant reduction in hydrocodone exposure in overdose scenarios versus generic hydrocodone. For more information, please visit . SOURCE Elysium Therapeutics 21% more press release views with Request a Demo

14 Nov 2025

·www.drugs.com

Nonopioids Superior to Opioids on Day 1 After Third Molar Extraction

FRIDAY, Nov. 14, 2025 -- For patients undergoing impacted mandibular third molar extraction, nonopioid therapy provides superior pain control on day 1 and noninferior control to opioids on days 2 and 3, according to a research letter published online Nov. 6 in JAMA Network Open . Janine Fredericks-Younger, D.M.D., from the Rutgers School of Dental Medicine in Newark, New Jersey, and colleagues conducted a multisite, noninferiority trial to compare the analgesic effectiveness of a nonopioid combination ( ibuprofen 400 mg and acetaminophen 500 mg) with an opioid combination (hydrocodone 5 mg and acetaminophen 300 mg) for postoperative pain management after extraction of an impacted mandibular third molar. Of the 1,815 participants, 909 received a nonopioid combination and 906 received an opioid. The researchers found that on day 1, nonopioids provided superior pain relief for females and males (mean difference, −0.63 and −0.75, respectively). Nonopioids were noninferior on days 2 and 3 and during the postoperative period, with all confidence intervals within the margin of noninferiority. The nonopioid group had higher patient satisfaction, with 82.8 and 87.8 percent of females and males, respectively, reporting being extremely satisfied in the nonopioid group compared with 76.2 and 81.6 percent, respectively, in the opioid group (odds ratios, 1.51 and 2.20 for females and males, respectively). "We feel pretty confident in saying that opioids should not be prescribed routinely for dental procedures," Fredericks-Younger said in a statement. "Our nonopioid combination really should be the analgesic choice." One author disclosed ties to the pharmaceutical industry. Abstract/Full Text

Clinical Result

07 Nov 2025

·www.drugs.com

Wisdom Tooth Surgery? Opioids Not Necessary, Clinical Trial Finds

FRIDAY, Nov. 7, 2025 — Getting your wisdom teeth pulled? You don’t need opioids to deal with the pain of the extraction, a new study says. A combination of ibuprofen and acetaminophen provided better pain relief than hydrocodone with acetaminophen for the first two days after wisdom tooth surgery, researchers reported Nov. 6 in JAMA Network Open . Both men and women also had greater satisfaction post-op when using over-the-counter pain medications compared to opioids, researchers said. The sex-specific results are important because women consistently report higher pain levels after surgery, researchers said. "We wanted to determine whether the pain medication’s effects were consistent in males and females separately," said lead researcher Dr. Janine Fredericks-Younger , an associate professor at Rutgers School of Dental Medicine in Newark, New Jersey. "And what we found is that in both subgroups (males and females), the non-opioid was superior for that first day and night, and then no worse than the opioid for the rest of the post-op period,” Fredericks-Younger said in a news release. For the clinical trial, researchers recruited more than 1,800 men and women slated to undergo wisdom tooth extraction, a painful procedure that requires cutting into gums and sometimes removing bone. Such dental procedures are how many Americans are introduced to opioids, researchers said in background notes. Dentists wrote more than 8.9 million opioid prescriptions in 2022. "There are studies out there to show that when young people get introduced to opioids, as many have via wisdom tooth extraction, there's an increased likelihood that they'll eventually use them again, and then it can lead to addiction," Fredericks-Younger said. Roughly half of the trial participants received 400 milligrams of ibuprofen ( Advil , Motrin) and 500 milligrams of acetaminophen ( Tylenol ) for their pain, the study says, The other half got 5 milligrams of hydrocodone with 300 milligrams of acetaminophen. Patients tracked their pain twice a day for nine days using electronic diaries, noting not just their pain but also their sleep quality, ability to perform daily activities, and overall satisfaction. On every measure, the over-the-counter meds matched or beat the opioid, including better sleep and less interference with daily activities, the study found. Those prescribed opioids also were twice as likely to call back requesting additional pain meds, researchers found. "The results actually came in even stronger than we thought they would," senior researcher Dr. Cecile Feldman said in a news release. She’s dean of the Rutgers School of Dental Medicine. "We expected to find the non-opioid to be non-inferior, so that at least it was no worse than opioids,” she said. “We were surprised to see that it was actually superior." These results should limit the common dental practice of writing “just in case” opioid prescriptions for patients who are told to start with over-the-counter meds, researchers said. The American Dental Association already recommends against opioids as a first-line pain treatment, researchers noted. "How can we now, with the evidence and the knowledge that we have, eliminate these prescriptions from being written?" Fredericks-Younger said. Even though this study focused on wisdom tooth extractions, Feldman said the findings could apply to other dental procedures. "We feel pretty confident in saying that opioids should not be prescribed routinely for dental procedures," she said. "Our non-opioid combination really should be the analgesic choice." However, future studies are needed to see if the same holds true for other types of surgeries, particularly those to treat orthopedic injuries, Feldman added. Sources Rutgers University, news release, Nov. 6, 2025 JAMA Network Open, Nov. 6, 2025

Clinical Result

100 Deals associated with Hydrocodone bitartrate

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External Link

KEGG	Wiki	ATC	Drug Bank
-	Hydrocodone bitartrate	R05DA03	-

R&D Status

Approved

10 top approved records.

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

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Osteoarthritis	Phase 3	United States	Teva Branded Pharmaceutical Products R&D LLC	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

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01402375 (CTgov)	Phase 3	Analgesia \| Acute Pain	720	Hydrocodone (first trial) (Hydrocodone (First Trial))	kgkqemzyvz(kzsptgksfl) = dppikfcpqw iohokjddao (gkqoumbjgm, 1.7) View more	-	01 May 2018
				Codeine (Codeine (First Trial))	kgkqemzyvz(kzsptgksfl) = vbgmtdrmpq iohokjddao (gkqoumbjgm, 1.8) View more
NCT01240863 (CTgov)	Phase 3	Low Back Pain \| Osteoarthritis \| Chronic Pain	391	Placebo (Placebo (Double-blind Treatment Period))	ytdltnkvcr(glmckqrgju) = bsmqkwgteg jyudvmnwgq (zjgyhlikbq, 0.169) View more	-	05 Jun 2017
				Hydrocodone ER (Hydrocodone ER (Double-blind Treatment Period))	ytdltnkvcr(glmckqrgju) = sptxqfwuig jyudvmnwgq (zjgyhlikbq, 0.176) View more
NCT01922739 (CTgov)	Phase 3	Low Back Pain	182	Placebo+Hydrocodone ER	yhkviiqrll = afmsfdqnhp tckwiolglf (rqaezwhciy, fmzuztwkfv - bdfudaesrq) View more	-	02 Jun 2017
NCT01789970 (CTgov)	Phase 3	Low Back Pain	625	Placebo (Placebo (Double-blind Treatment Period))	nzdosaulvt(hatnsmrjqc) = hmnmnfufpz bodwfrzgur (bajiccrhwd, 0.145) View more	-	05 Apr 2017
				Hydrocodone ER (Hydrocodone ER (Double-blind Treatment Period))	nzdosaulvt(hatnsmrjqc) = hyfkxuyyxk bodwfrzgur (bajiccrhwd, 0.134) View more
NCT01517295 (CTgov)	Phase 4	Chronic Pain	30	Hydrocodone (Group 1)	tpodkufocj(cabxnfekaf) = vxaifdqxes prbwgnqtdv (jfqkgfpfbg, 0) View more	-	28 Jul 2016
				Hydrocodone (Group 2)	tpodkufocj(cabxnfekaf) = narkfeiecm prbwgnqtdv (jfqkgfpfbg, 0) View more
NCT01859715 (CTgov)	Not Applicable	Medication interactions	502	Oxycodone (Oxycodone Group)	ykwvndfaad(pkhgzdefaw) = ixvvvhbevx pndngttmyv (vkpsshjcly, wqabxxiuzn - dfugeqfjos) View more	-	05 May 2016
				Hydrocodone (Hydrocodone/Acetaminophen Group)	ykwvndfaad(pkhgzdefaw) = sltztdytbb pndngttmyv (vkpsshjcly, evrialctkh - lwaxybnoqa) View more
NCT01452529 (CTgov)	Phase 3	Low Back Pain	905	Hydrocodone bitartrate (Hydrocodone Bitartrate)	xprvrgyusr(xgoskwbvzf) = mvvmouejll bxkgrfesul (igbbxtkasm, 0.13) View more	-	04 Dec 2014
				Placebo to match hydrocodone bitartrate q24h tablets (Placebo)	xprvrgyusr(xgoskwbvzf) = dgcukitvek bxkgrfesul (igbbxtkasm, 0.13) View more
NCT01400139 (CTgov)	Phase 3	Chronic Pain	922	Hydrocodone bitartrate (HYD) (HYD Core Study)	vzylixftpt = aiuvoaxegz hchdzuclow (iprynlhaqh, pujkrcvumw - gimchpfpzw) View more	-	04 Dec 2014
				Hydrocodone bitartrate (HYD) (HYD Extension Period)	vzylixftpt = jypzmtqgfc hchdzuclow (iprynlhaqh, howsdwsbbz - bsemogeicm) View more
NCT01115569 (CTgov)	Phase 3	Chronic Pain	424	Hydrocodone Bitartrate (Open-label Hydrocodone Bitartrate Extended Release Capsules)	syfqhwwbpr(vdazhbcmhl) = hyalukgrif noapxhofju (dlufffxjrb, 2.2)	-	25 Apr 2014
				Hydrocodone Bitartrate (Conversion/Titration Phase)	attmmqhbnx(qsvxqhtdnl) = jxtycgieey jccfhkxqke (alxedizdvl, fbwsxbqvok - mdfrzxgnsi) View more
NCT01081912 (CTgov)	Phase 3	Low Back Pain	510	Hydrocodone bitartrate (Hydrocodone Bitartrate Capsules)	edydyanxnn(ejbtekklqf) = ajcvdxnlei hzuvpzdyxd (mryndottkh, 1.563)	-	21 Apr 2014
				Placebo (Placebo Comparator)	edydyanxnn(ejbtekklqf) = njzisvnjad hzuvpzdyxd (mryndottkh, 1.550)