UPDATE 1-Fibromyalgia drug study results positive
Dec 8 (Reuters) - Forest Laboratories Inc (FRX.N: Quote, Profile, Research, Stock Buzz) and Cypress Bioscience Inc (CYPB.O: Quote, Profile, Research, Stock Buzz) said their experimental drug to treat fibromyalgia, a chronic pain syndrome, showed positive results in a late-stage trial.
Shares of Forest Laboratories rose as much as 4 percent, while those of Cypress rose 9.5 percent.
According to the topline results, the drug, milnacipran, showed a high proportion of patients met either of the two criteria set for the trial, compared to a dummy drug, the companies said.
In February, U.S. health regulators had accepted for review the New Drug Application for milnacipran.
On Oct. 20, the companies said the U.S. Food and Drug Administration was not able to make a decision on whether to approve the drug by the scheduled date.
The agency was scheduled to take final action under the Prescription Drug User Fee Act by Oct. 18. The companies said the FDA has not requested any additional information from the companies but did indicate that a clinical data question related to the filing required confirmation.
In a joint statement Monday, the companies said the current late-stage study confirms the results of two other late-stage studies conducted earlier. |
