Ironwood Pharma's Combination Gout Drug Gets FDA Approval

Ironwood Pharmaceuticals, Inc. (NASDAQ:IRWD) announced that the FDA has approved its oral fixed-dose combination drug, Duzallo, for the treatment of hyperuricemia in patients with uncontrolled gout.

Duzallo is a once-daily fixed dose combination of Ironwood’s gout drug Zurampic (lesinurad) and generic drug allopurinol, which is currently the standard of care treatment. Zurampic was launched in Oct 2016. It is important to note that Duzallo's label carries a "black box" warning regarding the risk of acute renal failure.

Hyperuricemia is an excess of uric acid in the blood. Gout is a highly symptomatic and painful form of inflammatory arthritis caused by hyperuricemia, which can lead to flares.

With the approval, Duzallo is now the first FDA-approved fixed-dose combination drug that addresses both causes of hyperuricemia in gout - over-production and under-excretion of serum uric acid - with a single pill.

There is a significant need for medicines like Duzallo that can help patients with uncontrolled gout achieve target serum uric acid levels. Duzallo, which is expected to be launched in the fourth quarter of this year, is expected to be crucial to Ironwood’s portfolio of gout drugs, which presently includes Zurampic. However, the sales uptake of Zurampic has been slow. Ironwood estimates that the uncontrolled gout market represents peak U.S. sales potential of more than $300 million.

Ironwood bought the exclusive U.S. marketing rights to Zurampic and Duzallo from AstraZeneca plc (NYSE:AZN) in June last year.

Ironwood’s shares have underperformed the industry so far this year. Specifically, the stock has declined 5.8% during the period, while the industry recorded a decrease of 3.7%.

Ironwood presently carries a Zacks Rank #4 (Sell).

Stocks to Consider

Better-ranked stocks in the sector are Jazz Pharmaceuticals plc (NASDAQ:JAZZ) and Neos Therapeutics, Inc. (NASDAQ:NEOS) , both with a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Jazz’s shares up 26.4% this year so far while that of Neos Therapeutics are up 18%.

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