@BPharmCatalyst $TNXP
The U.S. Food and Drug Administration has assigned a Prescription Drug User Fee Act (PDUFA) target action date of August 15, 2025. If approved, Tonmya would be the first new drug approved for fibromyalgia in over 15 years.
@BPharmCatalyst $TNXP
This delivery method allows for rapid transmucosal absorption and limits the formation of norcyclobenzaprine, a long half-life metabolite.
@BPharmCatalyst $TNXP
In prior data, Tonmya demonstrated statistically significant improvement in reducing fibromyalgia-related pain and was generally well tolerated. The U.S. Food and Drug Administration has assigned a Prescription Drug User Fee Act (PDUFA) target action date of August 15
@BPharmCatalyst $TNXP
Common symptoms include widespread pain, fatigue, nonrestorative sleep, and cognitive disturbances, with current treatment options often failing to meet patient and physician expectations.
@BPharmCatalyst $TNXP
The pivotal Phase 3 RELIEF and RESILIENT trials evaluate the efficacy and safety of once-nightly TNX-102 SL 5.6 mg in patients with fibromyalgia, a condition that affects an estimated 6 to 12 million adults in the U.S., predominantly women.
@BPharmCatalyst $TNXP
Its lead product candidate is TNX-102 SL, branded as Tonmya, a patented sublingual formulation of cyclobenzaprine hydrochloride designed to bypass first-pass hepatic metabolism.
@SmallCapBob2 I appreciate you putting me on to this opportunity!!!
I got in on Novavax back in 2020 and had similar reward but played it poorly and got to aggressive. I think I have a better understanding now to take advantage of this gift ๐