Tonix Drops Fibromyalgia, Will Pursue PTSD Claim With Cyclobenzaprine Formulation
Failing to meet the primary endpoint of a Phase III trial of TNX-102 SL in fibromyalgia, cash-limited Tonix decides to focus on developing the drug for PTSD – which it thinks is the path of least regulatory resistance. A pair of pivotal trials is slated to commence in 2017.
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In an exclusive interview, Seth Lederman, CEO of New York-based Tonix Pharmaceuticals, talks about the company’s R&D rollercoaster ride and how it plans to keep its lead asset on track for approval as a treatment for post-traumatic stress disorder.
Tonix Pharmaceuticals, a specialty pharma company focused on CNS disorders and based in New York City, has completed a reverse merger transaction through a share exchange agreement with publicly traded Tamandare Explorations Inc. Through a share exchange, the shareholders of Tonix acquired control of Tamandare.
Jazz Pharmaceuticals will likely have to narrow the proposed indication for its formulation of sodium oxybate for fibromyalgia (JZP-6, also marketed as Xyrem for other indications), as well as sponsoring one or more additional clinical trials and sharpening the proposed Risk Evaluation and Mitigation Strategy. The company was surprised by the scope of the "complete response" letter, CEO Bruce Cozadd said during an Oct. 11 call, although the action itself was anticipated following a negative advisory committee review (1"Jazz Fibromyalgia Candidate Needs More Risk Management, Advisory Panel Tells FDA," "The Pink Sheet" DAILY, Aug. 20, 2010). According to Cozadd, the letter asks for "additional studies to collect data, to evaluate safety in patients who may be taking concomitant medications, and the need for additional information regarding the selection of the appropriate patient population for the product. It also cites the risk of accidental exposure in patient households, particularly given the second dose taken in the middle of the night." The firm also must work on the concentration and trade name