Fibromyalgia Drug Moves to Next Phase to Improve Pain and Sleep Quality

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It's been well established that patients with fibromyalgia have a poorer quality of sleep, and now a drug is showing positive results in combatting this common symptom.

It’s been well established that patients with fibromyalgia have a poorer quality of sleep, and now a drug is showing positive results in combatting this common symptom.

Tonix Pharmaceuticals developed Tonmya (TNX-102), a next-generation medication to treat fibromyalgia, post-traumatic stress disorder (PTSD), and episodic tension-type headaches. The researchers conducted the BESTFIT clinical study to assess the drug’s influence on sleep. The latest data on the 2.8 mg Tonmya tablets was presented at the 2015 ACR/ARHP annual meeting in San Francisco, California.

The phase 2b trial results included 172 patients with fibromyalgia. Of those, 88 patients were treated with Tonmya and the other 84 were given a placebo. After 12 weeks, 36 patients in the Tonmya group (41%) and 18 patients in the placebo group (21%) achieved top sleep tertile. Forty-two of the top sleep tertile patients experienced at least 30% pain improvement. Of those, 28 patients (67%) took Tonmya and 14 patients (33%) had the placebo.

“Our new analyses of the BESTFIT data show that those patients who reported the greatest improvement in sleep quality were the most likely to experience pain relief,” Seth Lederman, MD, Tonix’s chairman and CEO, said in a news release.

The findings suggest that treating and improving sleep quality can lead to better pain management.

“We also observed that the group treated with Tonmya was approximately twice as likely as placebo-treated patients to be in the top third of reported sleep quality improvement,” Lederman explained. “Among all patients in BESTFIT who ranked highest in reported sleep quality improvement, twice as many Tonmya-treated patients experienced at least a 30% improvement in their pain as compared to those treated with placebo.”

Tonmya is currently being assessed in the phase 3 AFFIRM study. The drug is being tested in 500 patients with fibromyalgia for 12 week to evaluate pain responses. The data is expected to be revealed in the third quarter of 2016. If all goes well, the medication will move to the new drug application (NDA) phase and eventually hit the market.