$TNXP Tonmya is one of the more ridiculous FDA approvals in recent memory and will most certainly be a commercial failure.
The approved label for fibromyalgia reads like a bad joke: A miniscule 0.5-point "improvement" in patient-reported pain scores — clinically meaningless.
Enroll enough patients in studies and you'll get a stat sig result even if the benefit is non-existent. That's Tonmya.
Worse here, however, is the drug's nasty side effects, mostly oral pain, numbness and ulcers caused by the sublingual delivery.
The FDA must have been forced to approve this drug bc 2 of 3 studies were stat sig, even if the real benefit was nil. It's also a reformulation of a 50-year-old generic muscle relaxant.
A zero.