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FDA Finalizes Guidance to Encourage Development of Novel Medicines to Treat Opioid Use Disorder americanpharmaceuticalreview
October 12, 2020
The U.S. Food and Drug Administration (FDA) issued a final guidance, “Opioid Use Disorder: Endpoints for Demonstrating Effectiveness of Drugs for Treatment” which is intended to help companies develop drugs to treat OUD and addresses the clinical ...
FDA Finalizes Guidance to Encourage Development of Novel Medicines to Treat Opioid Use Disorder americanpharmaceuticalreview
October 12, 2020
The U.S. Food and Drug Administration (FDA) issued a final guidance, “Opioid Use Disorder: Endpoints for Demonstrating Effectiveness of Drugs for Treatment” which is intended to help companies develop drugs to treat OUD and addresses the clinical ...
Braeburn Submits Request for Final Approval of BRIXADI for Opioid Use Disorder americanpharmaceuticalreview
June 11, 2020
Braeburn has requested final approval from the U.S. Food and Drug Administration (FDA) of the New Drug Application for BRIXADI™ (buprenorphine) weekly and monthly extended-release injection for the treatment of opioid use disorder (OUD).
Taking Buprenorphine for Opioid Use Disorder May Up Other Med Compliance drugs
August 22, 2019
Using buprenorphine to treat opioid use disorder (OUD) may increase adherence to treatments for other chronic conditions, according to a study published in the September issue of Medical Care.
Braeburn Announces Tentative FDA Approval of BRIXADI americanpharmaceuticalreview
December 27, 2018
Braeburn announced the U.S. Food and Drug Administration (FDA) has granted tentative approval of BRIXADI (buprenorphine) extended-release weekly (8mg, 16mg, 24mg, 32mg) and ......
FDA approves first prescription mobile app for opioid use disorder, courtesy of Sandoz and Pear Therapeutics pharmafile
December 12, 2018
A digital therapeutic launched by Pear Therapeutics and Novartis’ generics and biosimilars division Sandoz has become the first FDA-approved app of its kind for use in the treatment of opioid use disorder (OUD), it has emerged.
Opioid use disorder market to hit $4.8 billion by 2027, says GlobalData pharmafile
November 28, 2018
New findings released by analytics firm GlobalData indicates that the market for opioid use disorder therapies is set to grow to reach $4.8 billion by 2027, up from $3 billion a decade earlier in 2017 at a compound annual growth rate (CAGR) of 10.3%.
Integrating Treatment at the Intersection of Opioid Use Disorder and Infectious Disease Epidemics in Medical Settings newsnow
September 04, 2018
A Call for Action After a National Academies of Sciences, Engineering, and Medicine Workshop
FDA issues new guidelines for opioid use disorders meds biospectrumasia
August 08, 2018
The draft guidelines could make it easier for new treatments to be developed, as clinical trials can be based on other patient outcomes beyond reduction in drug use.
FDA Takes Steps to Advance Development of Products for Treating OUD americanpharmaceuticalreview
April 23, 2018
The U.S. Food and Drug Administration (FDA) announced the latest action to encourage and support the development of treatment options for people with opioid use disorder (OUD).