Flexion Therapeutics shares went 50% higher when they got a word from FDA that their clinical data results were acceptable for NDA or New Drug Application.
The company is a specialty pharmaceutical firm that focuses on the development and commercialization of non-opioid pain therapies. They focus on the local therapies for the treatment of various musculoskeletal conditions such as osteoarthritis, which is a type of degenerative arthritis. Their lead product candidate, Zilretta or also known as FX006 is an intra-articular, sustained-release and non-opioid investigational treatment for late-stage development of moderate to severe osteoarthritis pain.
A Roller Coaster Market Performance
For the past year, Flexion and their investors were in a roller coaster ride when it comes to their stock performance. Their shares were down in the Fall of 2015, when their lead product Zilretta Phase IIb Trial failed. But then they will able to manage to put the stocks upward in February when the late-stage trial scored a primary endpoint.
In their latest written communication with FDA, Flexion Therapeutics announced that the regulators endorsed their latest clinical trial findings as acceptable for NDA submission. So the company will now move forward with the pre-NDA meeting and file the application in the fourth quarter.
Zilretta or FX006 is an injectable drug which was based from the oldest treatment use for osteoarthritis where a steroid shot is put directly into the sore joint. It has a sustained-release corticosteroid with a polymer used to keep the steroid when it is needed. The effect can last for some weeks.
The two-late stage studies both compared the action of the drug with a placebo rather than a steroid shot. In the initial clinical trials, at 12 weeks the 20 mg dose failed to set apart itself from the placebo. But the 40 mg dose succeeded to distinguish itself against Placebo during the Phase III clinical trial.
Michael Clayman, CEO of Flexion Therapeutics said that the endorsement of FDA for the NDA submission of Zilretta represents a major step in the development and commercialization of the drug. It also brings the company a step closer to making it available in the market to serve the millions of patients suffering from knee osteoarthritis. Clayman noted that this drug is a good pain-relief option for the patients.
Moving from acceptable to support filling and to an endorsement is an impressive leap for Flexion Therapeutics.
Failure Won’t Stop Flexion
The approval process of Zilretta may not be easy considering their initial failed clinical trial results. But it doesn’t stop Flexion Therapeutics to keep on trying and improve their lead candidate drug to make it to the market. Although, they are still on the NDA stage, the investors are confident that they can make it up until the approval stage.
The patient suffering from moderate to severe osteoarthritis will also take benefit from this drug. They will have another option to try out in case the prior treatment is not effective. If more innovative drugs are available in the market, there will be a healthy competition which will benefit more patients in the long run.