Opioid Use Disorder
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Sign up freeTop drugs studied for this disease
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FDA approval · 2021-03-04FDA Approved: BUPRENORPHINE — Supplemental Application (Actavis Pharma, Inc.)
FDA approved a supplemental application for buprenorphine by Actavis Pharma, Inc.
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FDA approval · 2021-03-04FDA Approved: SUBLOCADE — Supplemental Application (Indivior Inc.)
FDA approved a supplemental application for SUBLOCADE (buprenorphine) submitted by Indivior Inc.
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FDA approval · 2021-03-04FDA Approved: BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATE — Supplemental Application (SpecGx LLC)
FDA approved a supplemental application for a generic buprenorphine hydrochloride and naloxone hydrochloride dihydrate product from SpecGx L…
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FDA approval · 2021-03-04FDA Approved: BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATE — Supplemental Application (Accord Healthcare, Inc)
FDA approved a supplemental application from Accord Healthcare, Inc. for a generic buprenorphine hydrochloride and naloxone hydrochloride di…
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CLINICAL_TRIALS trial_result · 2021-02-21Clinical Trial Update: Patient-Directed Postoperative Opioid Prescribing for Gynecologic Surgery [Phase 2, Phase 3]
Phase 2/3 trial updates on patient-directed postoperative opioid prescribing for gynecologic surgery.
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FDA approval · 2021-02-19FDA Approved: BUPRENORPHINE AND NALOXONE — Supplemental Application (Lannett Company, Inc.)
FDA approved a supplemental application for Lannett Company's buprenorphine and naloxone product, affirming its approval for use in treating…
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FDA approval · 2021-02-19FDA Approved: METHADONE HYDROCHLORIDE — Supplemental Application (Camber Pharmaceuticals, Inc)
FDA approved a supplemental application for Camber Pharmaceuticals' methadone hydrochloride, enabling an additional generic product supply u…
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FDA approval · 2021-02-18FDA Approved: METHADONE HYDROCHLORIDE — Supplemental Application (Aurolife Pharma, LLC)
FDA approved a supplemental application for methadone hydrochloride manufactured by Aurolife Pharma, LLC. This action updates the product's …
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FDA approval · 2021-02-18FDA Approved: METHADONE HYDROCHLORIDE — Supplemental Application (SpecGx LLC)
FDA approved a supplemental application for methadone hydrochloride from SpecGx LLC.
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FDA approval · 2021-02-16FDA Approved: BUPRENORPHINE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)
FDA approved a supplemental application for buprenorphine from Sun Pharmaceutical Industries under ANDA201760, related to a supplemental app…
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FDA approval · 2021-02-16FDA Approved: BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATE — Supplemental Application (SpecGx LLC)
FDA approves SpecGx LLC's supplemental application for buprenorphine hydrochloride and naloxone hydrochloride dihydrate, enabling a generic …
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CLINICAL_TRIALS withdrawal · 2021-02-12Clinical Trial Update: Virginia Opioid Treatment-Emergency Department [Phase 3]
A Phase 3 clinical trial for opioid use disorder conducted by Virginia Commonwealth University has been withdrawn.
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FDA approval · 2021-02-08FDA Approved: METHADONE HYDROCHLORIDE — Supplemental Application (SpecGx LLC)
FDA approved a supplemental application for methadone hydrochloride submitted by SpecGx LLC. This action updates the regulatory status of th…
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FDA approval · 2021-02-04FDA Approved: BUPRENORPHINE AND NALOXONE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)
FDA approved a supplemental application for Buprenorphine and Naloxone by Sun Pharmaceutical Industries, Inc. under an ANDA, indicating regu…
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FDA approval · 2021-02-02FDA Approved: BUPRENORPHINE — Supplemental Application (Amneal Pharmaceuticals NY LLC)
The FDA approved a supplemental application for buprenorphine submitted by Amneal Pharmaceuticals NY LLC.
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CLINICAL_TRIALS trial_result · 2021-01-25Clinical Trial Update: SUBLOCADE Rapid Initiation Extension Study [Phase 4]
Phase 4 trial update for SUBLOCADE evaluating rapid initiation extension in adults with opioid use disorder; the study is completed with res…
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FDA approval · 2021-01-14FDA Approved: BUPRENORPHINE HCL AND NALOXONE HCL — Supplemental Application (Amneal Pharmaceuticals LLC)
FDA approved a supplemental application for Amneal's generic buprenorphine HCl and naloxone HCl product.
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FDA approval · 2021-01-13FDA Approved: BUPRENORPHINE AND NALOXONE — Supplemental Application (Actavis Pharma, Inc.)
The FDA approved a supplemental application for Buprenorphine and naloxone from Actavis Pharma, Inc., authorizing changes to the approved pr…
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CLINICAL_TRIALS trial_result · 2020-12-09Clinical Trial Update: SUBLOCADE Rapid Initiation Study [Phase 4]
Phase 4 study evaluating rapid initiation of SUBLOCADE for opioid use disorder, with results posted in December 2020.
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CLINICAL_TRIALS trial_result · 2020-11-12Clinical Trial Update: Drug Interaction and Subjective Effects of Compounds for Opioid Use Disorder [Phase 1]
Phase 1 clinical trial assessing drug interaction and subjective effects of compounds for opioid use disorder; completed with results posted…
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CLINICAL_TRIALS trial_result · 2020-11-10Clinical Trial Update: Effects of Buprenorphine/Naloxone Dose on Experimental Stress Reactivity and Opioid Abstinence [Phase 1, Phase 2]
A clinical trial update on buprenorphine/naloxone dosing and its effects on stress reactivity and opioid abstinence in heroin dependence and…
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FDA approval · 2020-11-02FDA Approved: METHADONE HYDROCLORIDE DYE-FREE, SUGAR-FREE, UNFLAVORED — Original Application (Lannett Company, Inc.)
FDA approved Lannett's methadone hydrochloride dye-free, sugar-free, unflavored product through an Original Application (ANDA), adding a new…
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CLINICAL_TRIALS trial_result · 2020-10-19Clinical Trial Update: Healthy Adult Male Facial Skin Surface Lipid Pheromone p.o. to Treat Opioid Addiction [Phase 3]
Phase 3 trial update for an oral facial skin lipid pheromone intended to treat opioid addiction appears to be in early or unknown status.
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CLINICAL_TRIALS withdrawal · 2020-10-14Clinical Trial Update: Long Acting Subcutaneous vs Short Acting Sublingual Buprenorphine in Pregnant and Lactating Women [Phase 4]
Phase 4 trial comparing long-acting subcutaneous buprenorphine to short-acting sublingual buprenorphine in pregnant and lactating women with…
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CLINICAL_TRIALS withdrawal · 2020-10-08Clinical Trial Update: An Open-Label, Single-Center Study to Evaluate the Exposure-Response Relationship Between the Plasma Drug Concentrations and the Change From Baseline in QTc at Steady State Following Once-daily Administration of CASSIPA® in Opioid Dependent Subjects. [Phase 4]
An open-label Phase 4 trial evaluating exposure–response for QTc changes with once-daily CASSIPA in opioid-dependent subjects was withdrawn.