The FDA has approved Nymalize (nimodipine; Arbor) oral solution for the treatment of patients experiencing symptoms resulting from a subarachnoid hemorrhage. Nimodipine is a calcium-channel blocker indicated to improve neurological outcome of subarachnoid hemorrhage from ruptured intracranial berry aneurysms, regardless of post-ictus neurological condition.
Nimodipine has been available as a 30mg liquid-filled gel capsule. However, the FDA has received reports of serious and fatal consequences (eg, death, cardiac arrest, severe hypotension, etc) from IV injection of the liquid contents of oral nimodipine capsules. In 2006, a Boxed Warning was added to the drug to warn against IV administration.
The approval of Nymalize is based on clinical studies evaluating the use of nimodipine oral capsules in patients with subarachnoid hemorrhage. Nymalize received fast track designation and priority review based on its potential to reduce medication errors.
Nymalize oral solution will be launched in the next few months.
For more information call (919) 792-1700 or visit the Arbor Pharmaceuticals website.