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Ironwood-Allergan Linzess Gets FDA Approval in Lower Dose

Ironwood Pharmaceuticals, Inc.IRWD and partner Allergan plc AGN announced that the FDA has approved a lower dose strength of Linzess (linaclotide) - 72 mcg - for the treatment of adult patients with chronic idiopathic constipation (CIC). The lower dose is expected to be available in the U.S. from the first quarter of 2017.

Linzess, Ironwood's sole marketed product, is available now in the U.S. for the treatment of adults with irritable bowel syndrome with constipation (IBS-C) or CIC. The drug is approved in the CIC indication as a 145 mcg capsule to be taken once daily. In the IBS-C indication, it is approved as a 290 mcg capsule to be taken once daily. Approval of a lower dose would provide patients with an additional treatment option.

Note that Linzess is marketed by Allergan for IBS-C in Europe under the brand name Constella. In Oct 2015, Allergan acquired exclusive rights for the development and commercialization of Linzess in the EU.

Shares of Ironwood have outperformed the Zacks classified Medical-Drugs industry in the last six months. The stock lost 2.7% during the period, while the industry registered a decline of 5.3%.

Approval of the new dose was supported by a phase III clinical trial on 1,223 adult patients with CIC. Data from the study showed that patients when treated with Linzess (72 mcg) demonstrated a statistically significant improvement compared to placebo on the 12-week complete spontaneous bowel movements (CSBM) overall responder endpoint, thereby meeting the primary endpoint of the study. Subsequently, in Jun 2016, the FDA accepted the companies' sNDA for a 72 mg dosage of Linzess for review.

Ironwood has partnered with Astellas Pharma for the development and commercialization of Linzess in Japan and with AstraZeneca plc AZN in China, Hong Kong and Macau.

Linzess has the potential to garner blockbuster sales. By the end of 2020, Ironwood expects annual sales of Linzess to cross $1 billion. The company is targeting at least three additional launches of Linzess by the end of 2018.

We remind investors that recently Synergy Pharmaceuticals Inc. SGYP gained FDA approval for Trulance (plecanatide) for the treatment of adults with CIC which could pose competition to Linzess.

Ironwood Pharmaceuticals, Inc. Price

Ironwood Pharmaceuticals, Inc. Price | Ironwood Pharmaceuticals, Inc. Quote

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Ironwood currently carries a Zacks Rank #3 (Hold). You can see the complete list of today's Zacks #1 Rank stocks here .

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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.


The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

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