Supernus' Trokendi XR Gets FDA Nod for Migraine in Adults
Supernus Pharmaceuticals, Inc. SUPN announced that the FDA has granted a tentative approval to the company’s supplemental New Drug Application (sNDA) for a label expansion for Trokendi XR to include prophylaxis of migraine headache in adults.
We note that Trokendi XR is already approved for the treatment of patients with epilepsy in the U.S. The drug is also approved for initial monotherapy in patients aged 6 years and older with partial onset or primary generalized tonic-clonic seizures, adjunctive therapy of patients in the same age group with partial onset or primary generalized tonic-clonic seizures, and adjunctive therapy of the same group of patients with seizures associated with Lennox-Gastaut syndrome.
The FDA’s approval of the sNDA was tentative as although it had determined that the drug met all of the required quality, safety and efficacy standards for approval, it is still subject to pediatric exclusivity which expires on Mar 28, 2017. A final approval might not be effective until this exclusivity period has expired.
Additionally, Supernus announced that the FDA has granted final approval to expand the label for Trokendi XR for monotherapy of partial onset seizures to include adults and pediatric patients aged 6 years and older, instead of the 10 years and older age group.
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We remind investors that Supernus had submitted the revised label for Trokendi XR requesting approval for a label expansion to include the treatment of migraine in adults in Jun 2016. The resubmission was requested by the FDA to review the proposed label in a different format. The FDA did not request for additional studies or new data. It had accepted the sNDA in Aug 2015.
The company will launch the drug for the migraine indication after receiving a full FDA approval. A final approval from the FDA will help boost its sales. Sales of Trokendi XR came in at $37.6 million on prescriptions of 93,094.
Supernus currently carries a Zacks Rank #3 (Hold). Investors interested in the health care sector may consider stocks like Pacira Pharmaceuticals, Inc. PCRX, Corcept Therapeutics Incorporated CORT and ANI Pharmaceuticals, Inc. ANIP. All of the three stocks sport a Zacks Rank #1 (Strong Buy).
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