Articles related to DEVICE/DRUG APPROVALS

The IV-equivalent formulation is indicated for the treatment of congestion due to fluid overload in people with NYHA class II/III chronic heart failure and may offer a substantial change in the management of the condition.

The obesity epidemic affects millions of patients around the world, but a new treatment option may be a game-changer for the treatment landscape. Lead author of the STEP 8 clinical trial, Dr. Domenica Rubino, shares insights from trial and how these key clinical findings could change obesity management.

In the phase III trial for zuranolone, 67.4% of patients who received an initial 2-week course at the 30-mg dose level initially achieved a 50% or greater reduction from baseline on the HAMD-17. Over the following year, half of those patients required additional 2-week courses of therapy. Of the group who received the 50-mg dose, only 25% needed subsequent courses.

Sufentanil sublingual tablet 30 mcg (Dsuvia, AcelRx), an effective novel tablet formulation of the synthetic opioid sufentanil, has been given FDA approval for the management of severe acute pain in adult patients in licensed medically supervised healthcare settings. The medication is administered sublingually in a single-dose, prefilled applicator.

Dextromethorphan HBr-buproprion HCl has been FDA approved in extended-release tablet form for MDD. The study supporting the approval showed improved MADRS total score at 6 weeks (15.9 points for Auvelity vs 12.1 points for placebo) and a statistically significant difference in the change from baseline in MADRS total score at weeks 1 and 2 between Auvelity (AXSOME) and placebo. “The approval of Auvelity represents a milestone in depression treatment based on its novel oral NMDA antagonist mechanism, its rapid antidepressant efficacy demonstrated in controlled trials, and a relatively favorable safety profile.” Maurizio Fava, MD, Psychiatrist-In-Chief, Massachusetts General Hospital

Paolo Manfredi, chief scientific officer at Relmada Therapeutics, remarked, “This designation further supports the potential of REL-1017 as a paradigm-shifting, novel standalone treatment for MDD, and highlights the significant unmet medical need in a therapeutic area where little has changed over the last several decades: available treatments remain inadequate for the majority of patients with MDD.”