oxycodone hydrochloride / Generic mfg. - LARVOL DELTA

Protega Pharmaceuticals collaborates with Wellgistics to support pharmacist education and increase patient access to the first and only FDA-approved abuse-deterrent immediate-release opioid, ROXYBOND (GlobeNewswire) - "Wellgistics Health...announced that its wholly owned subsidiary, Wellgistics LLC, is collaborating with Protega Pharmaceuticals Inc...Protega is the innovative specialty pharmaceutical company that launched ROXYBOND (oxycodone hydrochloride), the first and only FDA-approved abuse-deterrent immediate-release (IR) opioid pain medication in the U.S. The collaboration is meant to support pharmacist education on abuse-deterrent pain management options and regulatory compliance as well as increase patient access to ROXYBOND for appropriately prescribed patients....Through the collaboration, pharmacists will be provided with educational resources that both incorporate applicable FDA regulations, DEA guidelines, and best practices in responsible opioid dispensing and inform pharmacists about FDA-approved abuse-deterrent formulations like ROXYBOND and the role of these formulations in pain management."

Commercial • Pain

Protega Pharmaceuticals Receives FDA Approval for ROXYBOND (oxycodone hydrochloride) Immediate-Release 10 mg Tablet with Abuse-Deterrent Technology for Management of Pain (PRNewswire) - "Protega Pharmaceuticals Inc...announced today that the U.S. Food and Drug Administration (FDA) has approved ROXYBOND (oxycodone hydrochloride) immediate-release (IR) CII 10 mg tablet for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. ROXYBOND is the first and only FDA-approved abuse-deterrent IR 10 mg oxycodone formulation that is expected to reduce abuse by intranasal and intravenous routes."

FDA approval • CNS Disorders • Pain

[PREPRINT ] An Analysis of Oxycodone and Hydrocodone Distribution Trends in Delaware, Maryland, & Virginia between 2006-2014 (medRxiv) - P=N/A | N=N/A | “Results: There was a 57.59% in the weight of oxycodone and hydrocodone between 2006-2014. Oxycodone prescriptions increased by 75.50% and hydrocodone by 11.05%. Oxycodone increased across all three states between 2006-2010 and declined until 2014. Hydrocodone also increased but to a lesser extent than oxycodone. There was substantial variability in daily average dose of both opioids at the county level in all states. Pharmacies accounted for largest portion of oxycodone (69.17%) and hydrocodone (75.27%) purchased in the region. Hospitals accounted for 26.67% of oxycodone and 22.76% hydrocodone purchased.”

Preprint • Retrospective data • CNS Disorders • Pain

Steroids in Total Knee Arthroplasty (clinicaltrials.gov) - P4 | N=150 | Suspended | Sponsor: Emory University | Trial completion date: Jan 2022 ➔ Apr 2023 | Trial primary completion date: Jan 2022 ➔ Apr 2023

Trial completion date • Trial primary completion date • Immunology • Inflammation • Orthopedics • Osteoarthritis • Pain • Rheumatology

ERAS: Towards Enhanced Recovery After Cesarean (clinicaltrials.gov) - P1 | N=120 | Recruiting | Sponsor: University of Oklahoma | Trial completion date: Nov 2021 ➔ Apr 2023 | Trial primary completion date: Nov 2021 ➔ Apr 2023

Trial completion date • Trial primary completion date

Nonopioid Pain Control Regimen After Arthroscopic Hip Procedures (clinicaltrials.gov) - P4 | N=188 | Recruiting | Sponsor: Mayo Clinic | Not yet recruiting ➔ Recruiting | Trial completion date: Dec 2023 ➔ Apr 2023

Enrollment open • Trial completion date • Orthopedics • Pain

Evaluating the Abuse Potential of NEURONTIN® When Taken Orally Concomitantly With Oxycodone Hydrochloride in Healthy Non-drug Dependent, Recreational Opioid Users (clinicaltrials.gov) - P4 | N=54 | Completed | Sponsor: Viatris Specialty LLC

New P4 trial • Addiction (Opioid and Alcohol)

Decrease in Opioid Use Post-Vestibulectomy Based on Pre-Operative Low Intensity Vestibular Shockwave Therapy (LiSWT) (ISMST 2021) - "In this pilot study, pre-op LiSWT using Urogold 100 MTS decreased post-op opioid use after complete vestibulectomy with vaginal advancement flap. While encouraging, more research is needed."

Clinical

Relmada Therapeutics Announces Top-Line Results of Study Evaluating REL-1017 vs Oxycodone for Abuse Potential (PRNewswire) - P=NA, N=NA; "Relmada Therapeutics, Inc....announced today top-line results of the human abuse potential (HAP) study with REL-1017...Top-line results showed that all three doses of REL-1017 (25 mg, 75 mg and 150 mg, the therapeutic, supratherapeutic and maximum tolerated doses, respectively) tested in recreational opioid users, demonstrated a highly statistically significant difference vs. the active control drug, oxycodone 40 mg....'These data are consistent with our development program and confirm the extensive body of literature indicating the lack of abuse potential of REL-1017'....'These results are consistent with HAP results we have seen for other drugs that affect the CNS'..."

Clinical data • CNS Disorders • Depression • Major Depressive Disorder

A Single and Multiple Ascending Dose Study in Healthy Subjects to Assess the Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of KP-1199 (clinicaltrials.gov) - P1; N=97; Active, not recruiting; Sponsor: Kalyra Pharmaceuticals, Inc.; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed

Measuring Gait And Self-Reported Pain In Patients With Osteoarthritis Of The Knee Using Placebo/Oxycodone/Celecoxib. (clinicaltrials.gov) - P4; N=6; Terminated; Sponsor: Pfizer; Phase classification: P=N/A ➔ P4

Phase classification • Immunology • Osteoarthritis • Pain • Rheumatology

Pharmaceutical maker sues FDA for rejecting new approach to deterring opioid abuse (BioSpace) - "Pharmaceutical Manufacturing Research Services, Inc. (PMRS), a leading maker of pharmaceuticals for industry, has filed a petition asking the U.S. Court of Appeals for the District of Columbia Circuit to overturn the U.S. Food and Drug Administration's refusal to approve a new opioid capsule intended to deter abuse through a novel combination of physical properties and labeling changes. 'We presented a product that updates the opioid Roxicodone with a use indication for limited dosing and acute pain.'"

Corporate lawsuit