Articles related to DRUG APPROVALS

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.”

FDA approved new indications for these drugs in July, include a Janus kinase inhibitor and a phosphodiesterase-4 inhibitor for use in dermatology, a carbonic anhydrase inhibitor for partial-onset seizures, and an expanded indication for the TKI crizotinib.

Kar-XT adds trospium to xanomeline to substantially improve the second agent’s tolerability, enabling its use to reduce both positive and negative symptoms in schizophrenia. Allopregnanolone, an oral version of brexanolone, is being investigated in MDD. The dextromethorphan and bupropion combo, AXS-05, seeks to offer a new antidepressant option and hydroxynorketamine promises MDD treatment without ketamine’s dissociative effects and abuse potential.

The Emergency Use Authorization (EUA) for Paxlovid has been revised to reflect the new prescribing authority given to state-licensed pharmacists. Under this revision, patients must now show health records within the last year, which needs to include bloodwork, as well as a list of their current medications, including any over-the-counter (OTC).