Drugs

Relmada Depression Trial ‘Shows Promise’

Relmada Therapeutics says data from the Phase 3 REL-1017-310 Major Depressive Disorder (MDD) study shows that patients treated daily with REL-1017 for up to one year “experienced rapid, clinically meaningful, and sustained improvements in depressive symptoms and associated functional impairment.” It says REL-1017 was well-tolerated with long-term dosing, showing low adverse event rates and discontinuations. Relmada describes the drug as a new chemical entity and novel NMDA receptor channel blocker.

According to the company, de novo-treated patients had a baseline Montgomery-Åsberg Depression Rating Scale (MADRS) score of 33.8. “Treatment with REL-1017 in these patients resulted in mean improvements from baseline in the MADRS total score of 11.3 points at day 7, 16.8 points at month 1, 19.9 points at months 3 and 6, and 22.5 points at month 12,” it says. “The virtual absence of depressive symptoms (clinical remission) was achieved by 12.1% of de novo patients at day 7, 30.1% at month 1, 44.0% at month 3, 47.8% at month 6, and 54.4% at month 12. Clinical remission is defined as MADRS total score of less than or equal to 10.”

On the safety side, REL-1017 was safe and well-tolerated with a profile consistent with that observed in short-term controlled trials, the company says, adding that no new safety signals were detected in the study.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

Read more

Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome