Tonix Pharma Craters as Headache Drug Flunks Phase II Study
February 16, 2016
By Alex Keown, BioSpace.com Breaking News Staff
NEW YORK – Tonix Pharmaceuticals stock plunged more than 36 percent this morning after the company announced its experimental TNX-201 (dexisometheptene mucate) for the treatment of episodic tension-type headache, failed to beat placebo in Phase II trials.
In addition to its failure to meet the primary endpoint of participants becoming pain free from headaches at two hours after dosing, Tonix said the drug also failed secondary endpoints. At least 70 percent of patients taking the drug did not see a reduction in pain “from baseline on the Visual Analog Scale (VAS) at two hours after dosing, and an increase of the mean change from baseline to two hours post-dose in the VAS score.” The drug, however, was well tolerated by patients, the company said.
After failing to meet its endpoints, Tonix said it will discontinue all work with TNX-201.
“These results are disappointing, but we designed the study to challenge our hypothesis rapidly and with minimal capital investment. We are satisfied that we achieved a definitive outcome,” Seth Lederman, Tonix’s president and Chief executive officer said in a statement at Street Insider.
While work with TNX-201 will cease, Lederman said Tonix has other drug candidates that offer promising futures.
“We are excited to continue the rigorous execution of our registration-quality Phase II study of TNX-102 SL (cyclobenzaprine HCl sublingual tablets) in post-traumatic stress disorder, as well as our flagship development program, a Phase III trial in fibromyalgia of Tonmya (TNX-102 SL, cyclobenzaprine HCl sublingual tablets, 2.8 mg). We look forward to reporting data from, these studies, planned for the second and third quarters this year, respectively,” Lederman said.
The U.S. Food and Drug Administration has conditionally accepted “Tonmya” as the proposed trade name of TNX-102 SL for fibromyalgia, the company said.
Tonix stock is currently trading at $2.60 per share, down about 36 percent from its opening price. The stock has had a tumultuous year since its initial public offering for $7.50 per share in July. Since then the stock has hit a high of $10.72 per share and also seen a low of $2.49 per share.
The headache market is a lucrative market with pain relief treatments doing well. Earlier this year, the FDA approved Avanir Pharmaceuticals ’ Onzetra migraine medication, which is delivered as a unique nasal inhalant. Onzetra’s approval came after patients in clinical trials successfully self-administered the drug. Data from the trial showed patients reported headache relief at 30 minutes and at every time point up to two hours post-dose compared with those using the placebo.