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The U.S. Food and Drug Administration has advised Cambridge-based CombinatoRx Inc. (Nasdaq: CRXX) and Canada-based Neuromed Pharmaceuticals Inc. that the agency will put off making a decision on whether to approve the companies’ pain drug target for three months.
The FDA says it will now complete its review by February 22. While the FDA may approve the drug at that time. But company officials wrote in a statement, “the Exalgo NDA in its current form may not be sufficient to form the basis for approval” and that the companies may need to submit additional data.
The U.S. rights to Exalgo tablets were acquired from Neuromed by Mallinckrodt Inc., a subsidiary of Mansfield-based Covidien in June. Neuromed has so far received milestone payments totaling $15 million in relation to the drug target. Neuromed stands to receive milestone payments of up to $40 million if Exalgo is approved by the FDA.
CombinatoRx and Neuromed entered into a definitive merger agreement on June 30, and will hold stockholder meetings about the proposed merger on November 30.
Earlier this month, CombinatoRx said it narrowed its loss in the third quarter on aggressive cost cutting that resulted in a 36 percent reduction in its workforce.
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