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Tonix readies for pivotal Fibromyalgia program
Thursday 21 March 2013
In February 2013, Tonix Pharmaceuticals (TNXP.OB) management met face-to-face with the U.S. FDA to discuss the design of the clinical program for TNX-102SL, the company's low-dose sublingual formulation of cyclobenzaprine for the treatment of fibromyalgia syndrome. Management believes the results of the meeting were positive, and that a clear path to approval has been outlined. We discuss the proposed plan below:
During the third quarter 2013, Tonix plans to initiate a prospective Phase IIb study to assess the safety and efficacy of TNX-102SL in patients with fibromyalgia. The double-blind / placebo-controlled study will seek to enroll 100-200 patients with fibromyalgia at 10 centers all around the U.S. Patients will be randomized to receive either TNX-102SL (2.8mg) or placebo at bedtime nightly for 12 weeks. The primary endpoint will be pain severity at week 12 as assessed by the Numeric Rating Scale (NRS).
We note this endpoint is similar to that utilized by Pfizer (PFE) and Eli Lilly (LLY) to gain approval for Lyrica and Cymbalta, respectively, for the treatment of fibromyalgia syndrome. Placebo response will be a key issue to watch. Tonix plans to include a 1-2 week wash-out period prior to randomization. We note the Pfizer Phase III study with Lyrica showed a placebo response rate of nearly 50%.
The company will also collect information on secondary endpoints, including NRS scores at other time points during the 12 week study, the Fibromyalgia Impact Questionnaire (FIQ), and the Patient Global Impression of Change (PGIC). We suspect that the trial will take about 12 months to enroll and report top-line data, at an all-in cost of around $4-5 million.
If the proposed Phase IIb trial noted above is successful, Tonix plans to proceed into confirmatory Phase III registration study. We suspect that the Phase III study will follow a similar design to the proposed Phase IIb study, only slightly larger at 300 patients, and incorporate the same change in NRS from baseline to week 12 primary endpoint, and NRS, FIQ, and PGIC secondary endpoints. Assuming this study initiates late 2014, we believe data can be reported by the middle of 2016, allowing for a U.S. NDA filing in early 2017.
…Pharmacokinetic Reference Study…
Besides the two registration efficacy studies noted above, Tonix plans to conduct a multi-dose pharmacokinetic study with TNX-102SL in comparison to generic cyclobenzaprine in a multiple-day dosing (once daily) study. In the study, peak and trough blood levels of cyclobenzaprine will be measured in subjects that receive either TNX-102SL or generic cyclobenzaprine immediate release for 4-5 consecutive days. The goal of the study is to show a bridge between 2.8mg TNX-102SL and generic 5mg cyclobenzaprine that will allow for use of the generic tablet as a reference product in the planned 505(b)(2) NDA submission.
(Please note: The above was Page 1 of a 2-page article. Page 2 is available by subscription only.)
The above originally appeared here.
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