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Flexion Awaits FDA Word On Revised Zilretta Label

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Shares of Flexion Therapeutics Inc. (FLXN) are down nearly 14 percent from their 52-week high of $21.39, recorded as recently as last week, and trade around $18.

The Company's sole marketed product is Zilretta, a sustained-release corticosteroid polymer (PLGA) formulation, which was approved by the FDA in October 2017, for the management of osteoarthritis pain of the knee.

Since the launch of Zilretta in the fourth quarter of 2017, its sales have increased every quarter as shown by the numbers:

--$0.14Mln in Q4, 2017
--$2.2Mln in Q1, 2018
--$3.8Mln in Q2, 2018
--$7.0Mln in Q3, 2018
--$9.5Mln in Q4, 2018
--$10.6Mln in Q1, 2019
--$17.0Mln in Q2, 2019
--$21.8Mln in Q3, 2019

Currently, Zilretta is administered as a single intra-articular extended-release injection of triamcinolone acetonide, to deliver 32 mg (5 mL), and is not intended for repeat administration. Studies have shown that repeat administration of Zilretta can provide patients suffering from knee osteoarthritis consistent, substantial, and durable pain relief, and is generally well-tolerated.

The Company's request to revise the product label for Zilretta to allow for repeat administration is under FDA review, and the original decision date was on October 14, 2019.

However, on October 14, Flexion announced that the FDA requires additional time to complete the review of the supplemental New Drug Application related to repeat administration of Zilretta and that a decision can be anticipated in the coming weeks. Now, it's more than 2 months since the Company announced a delay in the decision.

Zilretta's potential is also being explored in shoulder osteoarthritis (OA) or adhesive capsulitis (AC), also known as frozen shoulder.

A phase II study of Zilretta that is designed to enroll up to 250 patients - approximately 135 with shoulder OA and 115 with shoulder AC - known as the RANGE study, is underway. The trial is expected to complete in the first half of 2021.

For full-year 2019, the Company has forecast net sales of Zilretta in the range of $70 million to $75 million. Net sales of the product were $22.5 million in 2018.

Will the Company's request to revise the product label of Zilretta pass muster? Stay tuned…

FLXN has traded in a range of $8.76 to $21.39 in the last 1 year. The stock closed Tuesday's trading at $18.45, down 3.45%.

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