Biopharmaceutical company CombinatoRx, Inc. (CRXX), which has agreed to merge with privately-held Neuromed Pharmaceuticals Inc., announced Monday that the U.S. Food and Drug Administration, or FDA, has indicated Neuromed that the pending New Drug Application for its paint tablet Exalgo is not sufficient in the current form to establish the basis for approval. Shares of CombinatoRx are currently trading down more than 47% on the Nasdaq.
The indication was made by FDA staff in course of a discussion on November 13 when representatives of Neuromed met the agency staff seeking approval for Exalgo. Neuromed is seeking Exalgo approval for the management of moderate to severe pain in opioid tolerant patients requiring continuous, around-the-clock opioid analgesia for an extended period of time. The FDA staff indicated that the NDA in its current form would not be sufficient to form the basis for approval of Exalgo under Section 505(1) of the Food, Drug and Cosmetic Act, or FDCA, of 1938, as amended.
Exalgo, or hydromorphone HCl extended release, tablets is an opioid formulation and an investigational drug studied in more than 2,000 pain patients in clinical trials.
Following discussions with the FDA, Neuromed said it is working with the drug's commercial rights owner, Mallinckrodt, Inc., to determine the appropriate actions to be taken, including amending the existing NDA, or potentially resubmitting the NDA under Section 505(b)(2) of the FDCA, which utilizes different criteria to determine the basis for approval of a new drug candidate.
The U.S. rights to Exalgo were acquired by Mallinckrodt, a subsidiary of Covidien Plc (COV), on June 11 for $15 million in upfront payments, additional development funding of up to $16 million to cover internal and external costs associated with Exalgo, an approval milestone of $30 million, which could potentially increase up to $40 million, and tiered royalties on Exalgo net sales after approval.
CombinatoRx and Neuromed have entered into a definitive merger agreement on June 30, under which CombinatoRx and Neuromed will merge in an all-stock transaction.
In Monday's regular trading session, CRXX is currently trading on the Nasdaq at $0.93 per share down $0.70 or 47.20% on a volume of 1.01 million shares. In the past 52-week period, the shares have been trading in a range of $0.25 to $2.60.
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