Ironwood Announces U.S. Availability Of ZURAMPIC (lesinurad) 200 mg Tablets For Patients With Uncontrolled Gout

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Ironwood Pharmaceuticals, Inc. (NASDAQ: IRWD) today announced that ZURAMPIC^® (lesinurad) is now available in pharmacies throughout the United States. ZURAMPIC is approved as a once-daily oral tablet to be taken in combination with a xanthine oxidase inhibitor (XOI) for the treatment of hyperuricemia – high serum uric acid (sUA) levels in the blood – associated with gout in patients who have not achieved target sUA levels with an XOI alone. ZURAMPIC is not recommended for the treatment of asymptomatic hyperuricemia and should not be used as monotherapy.

The safety and efficacy of ZURAMPIC were established in three Phase III, multicenter, randomized, double-blind, 12-month, placebo-controlled clinical studies in adult patients with hyperuricemia and gout. In two of the trials, ZURAMPIC was studied in combination with allopurinol and in a third trial was studied in combination with febuxostat. Allopurinol and febuxostat are each XOIs. In clinical trials, when added to allopurinol in patients with gout who failed to achieve target sUA levels with allopurinol alone, ZURAMPIC nearly doubled the number of patients who achieved sUA target of <6 mg/dL at month 6, reduced the mean sUA to <6 mg/dL by month 1 and maintained that level through month 12. When added to febuxostat 80 mg in clinical trials, ZURAMPIC helped a greater, but not statistically significant, proportion of patients with tophaceous gout achieve sUA <5 mg/dL at month 6, and maintained that level through month 12. Acute renal failure has occurred with ZURAMPIC and was more common when ZURAMPIC was given alone. ZURAMPIC should be used in combination with an XOI. Most common adverse reactions with ZURAMPIC in the clinical trials were headache, influenza, blood creatinine increased, and gastroesophageal reflux disease.

About Hyperuricemia and Gout
Gout is a highly symptomatic and painful form of inflammatory arthritis affecting an estimated eight million people in the U.S. It is caused by an underlying metabolic disorder, hyperuricemia – high levels of uric acid in the blood – and can lead to painful flares, characterized by excruciating pain, inflammation, swelling and tenderness in one or more joints. Gout is commonly hereditary and not only a lifestyle disease. While diet and lifestyle changes are important in managing gout and its comorbidities, they are often not enough to get patient serum uric acid (sUA) levels to target.

Approximately four million patients are treated with a xanthine oxidase inhibitor (XOI), either allopurinol or febuxostat, for gout in the U.S. Of these, an estimated two million patients are uncontrolled and are not achieving target serum uric acid (sUA) levels <6 mg/dL as recommended by the American College of Rheumatology, despite treatment with an XOI alone. These patients continue to suffer from flares despite treatment with an XOI alone, and may face serious long-term consequences that can result from having uncontrolled sUA levels.

About ZURAMPIC^® (lesinurad) 200 mg tablets

ZURAMPIC® (lesinurad) is a URAT1 inhibitor approved by the FDA for use in combination with a xanthine oxidase inhibitor (XOI) for the treatment of hyperuricemia associated with gout in patients who have not achieved target serum uric acid levels (sUA) with an XOI alone. ZURAMPIC is not recommended for the treatment of asymptomatic hyperuricemia and should not be used as a monotherapy. XOIs reduce the production of uric acid; ZURAMPIC increases renal excretion of uric acid by selectively inhibiting the action of URAT1, the UA transporter responsible for the majority of renal UA reabsorption. The dual-mechanism combination of ZURAMPIC plus an XOI (allopurinol or febuxostat) can address both inefficient excretion and overproduction of UA, thereby lowering sUA levels. The safety and efficacy of ZURAMPIC were established in three Phase III clinical trials that evaluated a once-daily dose of ZURAMPIC in combination with the XOI allopurinol or febuxostat compared to XOI alone. Visit www.zurampic.com for more information about ZURAMPIC.

Contraindications:

• Severe renal impairment (eCLcr less than 30 mL/min), end-stage renal disease, kidney transplant recipients, or patients on dialysis
• Tumor lysis syndrome or Lesch-Nyhan syndrome

Warnings and Precautions:

• Renal events: Adverse reactions related to renal function have occurred after initiating ZURAMPIC. A higher incidence was observed at the 400-mg dose, with the highest incidence occurring with monotherapy use. Monitor renal function at initiation and during therapy with ZURAMPIC, particularly in patients with eCLcr below 60 mL/min or with serum creatinine elevations 1.5 to 2 times the pre-treatment value, and evaluate for signs and symptoms of acute uric acid nephropathy. Interrupt treatment with ZURAMPIC if serum creatinine is elevated to greater than 2 times the pre-treatment value or if there are symptoms that may indicate acute uric acid nephropathy. ZURAMPIC should not be restarted without another explanation for the serum creatinine abnormalities. ZURAMPIC should not be initiated in patients with an eCLcr less than 45 mL/min.

• Cardiovascular events: In clinical trials, major adverse cardiovascular events (defined as cardiovascular deaths, non-fatal myocardial infarctions, or non-fatal strokes) were observed with ZURAMPIC. A causal relationship has not been established.

Adverse Reactions:

• Most common adverse reactions with ZURAMPIC (in combination with an XOI and more frequently than on an XOI alone) were headache, influenza, blood creatinine increased, and gastroesophageal reflux disease.

Indication and Limitations of Use for ZURAMPIC:
ZURAMPIC is a URAT1 inhibitor indicated in combination with an XOI for the treatment of hyperuricemia associated with gout in patients who have not achieved target serum uric acid levels with an XOI alone.

• ZURAMPIC is not recommended for the treatment of asymptomatic hyperuricemia
• ZURAMPIC should not be used as monotherapy

Please see full Prescribing Information, including Boxed WARNING, http://www.azpicentral.com/zurampic/zurampic.pdf

About Ironwood Pharmaceuticals
Ironwood Pharmaceuticals (NASDAQ: IRWD) is a commercial biotechnology company focused on creating medicines that make a difference for patients, building value for our fellow shareholders, and empowering our passionate team. We are advancing a pipeline of innovative medicines in areas of significant unmet need, including irritable bowel syndrome with constipation (IBS-C)/chronic idiopathic constipation (CIC), uncontrolled gout, refractory gastroesophageal reflux disease, and vascular and fibrotic diseases. We discovered, developed and are commercializing linaclotide, the U.S. branded prescription market leader in the IBS-C/CIC category, and we are applying our proven R&D and commercial capabilities to advance multiple internally-developed and externally-accessed product opportunities. Ironwood was founded in 1998 and is headquartered in Cambridge, Mass. For more information, please visit www.ironwoodpharma.com or www.twitter.com/ironwoodpharma; information that may be important to investors will be routinely posted in both these locations.