Flexion Therapeutics, Inc. FLXN announced that it enrolled the first patient in a phase III study on its pain drug, Zilretta (triamcinolone acetonide extended-release injectable suspension), for the treatment of patients with hip osteoarthritis (OA) on Dec 26, 2018. This late-stage study will evaluate the safety and efficacy of Zilretta, already approved by the FDA for pain management in patients with knee OA since October 2017.
Zilretta was approved as the first and the only extended-release intra-articular (IA) therapy, providing relief from pain for over a period of 12-weeks.
The initiation of this phase III program was based on positive data from the open-label phase II SHIP study. Data from the latter showed that Zilretta was safe and well tolerated. The final result read-out from this label expansion analysis is expected in 2020.
The phase III study will evaluate Zilretta on 440 patients with hip OA. Patients were randomly administered with either a single IA injection of Zilretta or placebo. The primary endpoint of the study is to assess the pain relief at week 12 compared with placebo measured by the WOMAC scale.
Flexion also plans to begin additional phase II studies on Zilretta for treating shoulder OA and shoulder adhesive capsulitis (frozen shoulder) later this year.
Shares of Flexion have plummeted 51.2% in the past year, significantly wider than the industry’s decline of 20.6%.
Osteoarthritis is the most common form of arthritis, which can aggravate to become an incurable condition, ultimately causing total joint replacement.
Flexion estimates that roughly 25% of Americans may develop symptomatic hip OA in their lifetime. Therefore, the approval of this expanded indication will help the company gain an access to a broader patient population and boost the drug’s sales.
Zacks Rank & Stocks to Consider
Flexion currently carries a Zacks Rank #3 (Hold). Better-ranked stocks in the same sector include BioSpecifics Technologies Corp BSTC, Hikma Pharmaceuticals Plc HKMPF and Cumberland Pharmaceuticals Inc. CPIX, all sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
BioSpecifics’ earnings estimates have been revised 16.8% upward for 2019 over the past 60 days. The stock has surged 37% in the past year.
Hikma’s earnings estimates have moved 14.8% north for 2019 over the past 60 days. The stock has soared 41.4% in a year.
Cumberland’s loss per share estimates has been narrowed 48.9% for 2019 in the last 60 days.
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