Tonix's fibromyalgia drug Tonmya reaches about $15m in quarterly sales as generic challenger appears

Tonix Pharmaceuticals is reporting growing sales of its first commercial product while also facing a generic competitor. Third-quarter net sales of Tonmya, a sublingual cyclobenzaprine for adults with fibromyalgia, were about $15.0m, 37% higher than in the second quarter, the company said on 9 November.

In the same update, Tonix disclosed that Dr. Reddy's has submitted an abbreviated new drug application to the US Food and Drug Administration for a generic version. The filing carries a Paragraph IV certification and Tonix said it intends to assert its patents. By way of context, such a certification argues that a listed patent is invalid or would not be infringed, and it can lead to litigation. The summary available does not say which patents are involved or give any timetable.

On access, Tonix said payer coverage for Tonmya now spans roughly 166 million US lives. The company did not provide a breakdown by payer type or any information on pricing or prescription volumes.

The balance sheet shows the cost of building the business. Tonix closed the quarter with about $163m in cash and booked a net loss of $53.3m. It expects that cash to last into early the third quarter of 2027. The pipeline update covered TNX-102 SL in major depressive disorder, TNX-4800 for Lyme disease and TNX-1500, and for TNX-4800 the company pointed to minutes from an FDA Type C meeting. No further detail on those programmes was available.