Drugs

Vanda Pharmaceuticals Puts Social Anxiety Drug On Hold

Vanda Pharmaceuticals says its development program for VQW-765, a novel small molecule alpha 7 nicotinic acetylcholine receptor partial agonist, is on hold after the therapy failed to meet its primary endpoint in a Phase 3 clinical study in patients with social anxiety.

The study, VP-VQW-765-3201 (Study 3201), was evaluating VQW-765 for the on-demand treatment of acute anxiety in adults with social anxiety disorder. The study randomized 546 adults 18 to 65 years of age with a current diagnosis of social anxiety disorder and elevated baseline scores on the Liebowitz Social Anxiety Scale and Public Speaking Anxiety Scale.

Participants received a single oral dose of VQW-765 or placebo and were then challenged with a psychosocial stress test, the standardized Trier Social Stress Test (TSST). TSST is designed to “induce acute stress by having participants prepare (anticipation phase) and then deliver (performance phase) an interview-style presentation to a panel that gives no feedback or encouragement,” the company says.

Over 20% of the U.S. population is estimated to experience debilitating performance anxiety that ranges from public speaking to test taking, writer's block and musical performance.

Adulterated Drugs at SCA Outsourcing Facility: FDA

A 10/20-10/30/2025 FDA inspection at SCA Pharmaceuticals’ outsourcing facility in Little Rock, AR, found serious deficiencies in the firm’s practices for producing drug products that are intended or expected to be sterile. A just-released 9/14 Warning Letter says the agency investigator collected evidence

Require Postmarket Studies, Registry for Some Anti-Depressants: Petition

The Antidepressant Coalition for Education is petitioning FDA to require postmarketing studies and a national patient registry for selective serotonin reuptake inhibitors (SSRI) and serotonin-norepinephrine reuptake inhibitors (SNRI). The petition says the patient registry should prospectively follow patients during and after SSRI or SNRI tapering or discontinuation and should

Lowest Job Ranking for FDA: Poll

Aquestive’s NDA Resubmission Accepted for Review

FDA has accepted for review an Aquestive Therapeutics NDA resubmission for Anaphylm (dibutepinephrine) sublingual film for treating Type I allergic reactions, including anaphylaxis. The agency has set a review action target date of 3/16/2027. In January, FDA issued the company a complete response letter (CRL) on the original

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Adulterated Drugs at SCA Outsourcing Facility: FDA

Require Postmarket Studies, Registry for Some Anti-Depressants: Petition

Lowest Job Ranking for FDA: Poll

Aquestive’s NDA Resubmission Accepted for Review