The Food and Drug Administration Friday approved a new dosage option for buprenorphine and naloxone sublingual film, applied under the tongue as a maintenance treatment for opioid dependence. The medication-assisted treatment was approved through an abbreviated pathway under the Federal Food, Drug, and Cosmetic Act, which may rely on the FDA’s finding that a previously approved drug is safe and effective. “There’s an urgent need to ensure access to, and wider use and understanding of, medication-assisted treatment for opioid use disorder,” said FDA Commissioner Scott Gottlieb, M.D. “The introduction of new treatment options has the potential to broaden access for patients.”
 

Related News Articles

Headline
The National Academies of Sciences Engineering, and Medicine yesterday released recommendations for improving outcomes and metrics associated with four grant…
Headline
The Centers for Medicare & Medicaid Services recently announced a six-month delay in implementation of its Innovation Center Maternal Opioid Misuse (MOM)…
Headline
Sens. Jon Tester, D-Mont., and John Hoeven, R-N.D., yesterday introduced AHA-supported legislation (S. 3399) that would renew for five years a…
Headline
Mallinckrodt Pharmaceuticals today announced an agreement in principle on a settlement to resolve all opioid-related claims against the company in…
Headline
Public and private entities can apply for $1 million grants for a three-year period to enhance or expand opioid and other substance use disorder services in…
Headline
Rep. Vicky Hartzler, R-Mo., House Energy and Commerce Committee Ranking Member Greg Walden, R-Ore., and other Republicans on the committee last week asked the…