Sunovion Sees Advantage For Aptiom As Unscheduled Epilepsy Drug
This article was originally published in The Pink Sheet Daily
Dainippon subsidiary plans to launch its next-generation version of carbamazepine in the second half of 2014. Lack of classification as a controlled substance means more direct access to prescribers, company says.
You may also be interested in...
FDA officials explain why randomized clinical trials of Ebola products are necessary and the Senate passes Ebola priority review voucher bill. Lilly/AstraZeneca start Alzeimer’s trial, Incyte gains new approval for Jakafi, Sunovion files for new use of Aptiom and AstraZeneca resubmits its once withdrawn lung cancer drug Iressa.
FDA is showing a renewed commitment to meeting review deadlines for new molecular entities, but that is not translating into earlier commercial availability for all NMEs. Some products also need a controlled substance scheduling decision from the Drug Enforcement Administration; those actions have become a new regulatory purgatory that can be painful and frustrating.
Much of the drug development activity in epilepsy is focused on improving the existing treatments.