Federal regulators have approved a new label for Vivus’ impotence drug, stating that it becomes effective in half the time that the previous label had stated.
Shares jumped more than 14 percent in Thursday trading.
The label on Stendra now reads that the drug can be taken approximately 15 minutes before sex. Previously approved prescribing information recommended that patients take the drug about 30 minutes before.
Rival drugs used to treat erectile dysfunction, such as Pfizer Inc.’s Viagra, are supposed to be taken at least 30 minutes before sex.
The Food and Drug Administration approved Stendra in April 2012 with that 30-minute label. But Vivus has sought a new label after finding in studies that some patients were able to have sex as little as 15 minutes.
Vivus also makes the obesity drug Qsymia. Last fall, it sold the rights to sell Stendra in the United States and Canada to Auxilium Pharmaceuticals Inc. in a deal that could be worth $300 million, depending on royalty payments.
Date: September 18, 2014
Source: Associated Press