Drugs

FDA OKs Tonix Drug for Fibromyalgia

FDA has approved a Tonix Pharmaceuticals NDA for Tonmya (cyclobenzaprine HCl sublingual tablets), a once-daily, non-opioid drug for treating fibromyalgia in adults. Tonmya is taken at bedtime and uses a sublingual formulation designed for rapid absorption. In clinical trials, the drug was shown to significantly reduce daily pain scores and improve sleep quality, a major issue for many fibromyalgia patients, according to the company.

FDA’s decision was based on data from two Phase 3 randomized, placebo-controlled studies involving nearly 1,000 patients, according to the company. Participants taking Tonmya reported meaningful pain reduction over 14 weeks compared to placebo. A larger proportion also achieved at least a 30% improvement in pain, a benchmark used in chronic pain trials, it says.

Tonix says Tonmya was generally well-tolerated, and the most common side effects included numbness or tingling in the mouth, unusual taste, drowsiness, oral discomfort, fatigue, and dry mouth.

Fibromyalgia affects about four million adults in the U.S., according to the company, adding that symptoms include widespread chronic pain, fatigue, sleep disturbances, and cognitive difficulties.

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

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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