Tonix Pharmaceuticals has presented data for TNX-102 SL (cyclobenzaprine [CBP] HCI sublingual tablets, 2.8 mg), its investigational new drug, at the American Society for Clinical Pharmacology and Therapeutics 2016 Annual Meeting, held March 8 -12 in San Diego, California.
The poster presentation, “Rapid Sublingual Absorption on Cyclobenzaprine (CBP) with Basifying Agents: Prospect for Bedtime Treatment of Fibromyalgia Syndrome (FM),” showed the drug’s potential for the treatment of post-traumatic stress disorder (PTSD) and for the long-term management of fibromyalgia.
TNX-102 SL has been approved by the U.S. FDA as an Investigational New Drug, but it has not yet been approved as a therapy for any condition. Also, the FDA has conditionally accepted the proposed trade name Tonmya for TNX-102 SL.
New York City-based Tonix is now evaluating TNX-102 SL in the randomized, double-blind, placebo-controlled, registration-quality Phase II AtEase clinical trial in PTSD triggered by military functions; and in the randomized, double-blind, placebo-controlled 12-week Phase III AFFIRM clinical trial for fibromyalgia.
According to a press release, pharmacokinetic data has revealed that:
- TNX-102 SL shows evidence of rapid delivery of CBP across the sublingual mucosal membrane into plasma, resulting in 12 times faster absorption relative to the oral CBP immediate release (IR) tablet;
- TNX-102 SL increased plasma levels of 338 percent during the first hour and 83 percent in the first two hours after administration, compared with the oral CBP IR tablet;
- The relative bioavailability of cyclobenzaprine is 154 percent with TNX-102 SL compared to the oral CBP IR tablet;
- The active metabolite, norcyclobenzaprine, is reduced by 48 percent with TNX-102 SL;
- The most frequent adverse event reported in this single-dose comparative bioavailability/pharmacokinetic study was transient numbness in the oral cavity, which was experienced in 50 percent of the TNX-102 SL subjects. It was resolved within 30-45 minutes.
The encouraging results show that TNX-102 SL’s design has more desirable properties due to its pharmacokinetic profile, making it a better bedtime medication for fibromyalgia or PTSD.
Tonix is expecting top-line data for the AtEase trial to be reported during the first half of 2016 and during the second semester of 2016 for the AFFIRM trial. The poster of TNX-102 SL administered at bedtime was presented by Tonix CSO Bruce Daugherty, Ph.D .