The first drug developed by Flexion Therapeutics Inc (NASDAQ:FLXN) for the treatment of osteoarthritic knee pain has been approved by the U.S. Food and Drug Administration. The company currently boasts a sales force consisting of 103 professionals.
Zilretta, a non-opioid injection which offers relief from osteoarthritic knee pain for a period of 12 weeks, was granted approval on the basis of a phase III study which was conducted on 484 patients in 37 centers located around the world.
Hip and shoulder pain
Approximately 14 million people in the United States are afflicted with the condition. According to David Marris, an analyst at Wells Fargo, five million of these people get treatment through injections on an annual basis. Flexion Pharmaceuticals is of the view that its sales force is capable of covering 9,000 rheumatologists and orthopedists with a view to reaching over 75% of the market.
“[Doctors are excited about the drug and] they will use it in a large number of patients, and even use it off-label in hips and shoulders,” wrote Maris in a note after conducting a survey of professionals in the medical field.
In order to guide the development of the treatment executives of Flexion Pharmaceuticals have said the firm will start trials focusing on osteoarthritic shoulder and hip pain. Some of the aspects of the official FDA label granted to Zilretta that have won the praise of executives and analysts include the fact that the data demonstrate the safety of the treatment in patients suffering from diabetes.
The U.S. FDA has also not requested a postmarketing study of the treatment. Additionally the FDA has stipulated that the treatment can be kept at room temperatures for a period of up to six weeks and this allows treatment centers a lot of flexibility.
The full rollout of Zilretta s not expected until the Thanksgiving weekend. Next year is slated to be the foundational year of the drug and 2019 the growth year according to executives.
On Monday shares of Flexion Therapeutics Inc fell by 5.65% to close the day at $28.24.