The U.S. Food and Drug Administration agreed Tuesday to loosen restrictions on the way Vivus' Qsymia can be prescribed, allowing the weight-loss pill Qsymia to be dispensed from retail pharmacies. When approved last year, FDA restricted the drug's distribution to mail-order pharmacies due to concerns about the risk of birth defects.
Vivus has blamed Qsymia's disappointing launch, in part, on the mail-order pharmacy restriction. Sales totaled $2 million in the fourth quarter, well below investor expectations.
"Our goal over the next three months is to ensure availability of Qsymia in thousands of certified retail pharmacies nationwide," said Vivus President Peter Tam, in a statement. "The REMS modification is a key accomplishment in removing a major barrier that has hindered the initial acceptance of Qsymia into everyday medical practice. We believe that retail access, along with ongoing improvements in reimbursement, will help to accelerate Qsymia awareness, trial and usage."Vivus shares spiked above $12 per share when the Qsymia announcement hit the tape Tuesday afternoon but shares are now trading up 5% to $11.70. Arena Pharmaceuticals (ARNA), which hopes to compete against Vivus with its own obesity pill Belviq, has been waiting nine and half months for DEA to finalize scheduling. -- Reported by Adam Feuerstein in Boston. Follow @AdamFeuerstein
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