Fingolimod Issued a Safety Warning, an NDA for BHV-0223 for ALS, and Lifestyle Modifications for Patients with Migraine
Neurology News Network for the week of December 1, 2018.
PUBLISHED December 08, 2018
This week, Neurology News Network covered the issuance of an FDA safety alert warning that halting treatment with fingolimod for multiple sclerosis could lead to rare but posisble worsening of the condition in addition to permanent disability. We also covered the FDA acceptance of Biohaven Pharmaceutical's BHV-0223, an investigational sublingual form of riluzole for treatment of ALS, as well as Stephen Silberstein's, MD, perspective on the importance of lifestyle modifications for patients suffering from chronic migraine. (Transcript below.)
Welcome to Neurology News Network. I’m Jenna Payesko. Let’s get into the news.
The FDA issued a safety alert and warned that halting treatment with fingolimod for multiple sclerosis could lead to rare but possible worsening of the condition, as well as permanent disability.
Originally approved in 2010, fingolimod is used to treat relapsing MS. The agency recommended that health care professionals inform their patients before starting treatment about the potential risk of a severe increase in disability after stopping fingolimod.
For patients who have been instructed to stop fingolimod, the FDA suggested contacting their health professional immediately if you experience new or worsened symptoms such as weakness, trouble using arms or legs, and changes in thinking, eyesight, or balance. They advise against patients halting the medicine on their own, and suggested speaking to their health professional first.
Last week, the FDA accepted the new drug application filing of Biohaven Pharmaceutical’s BHV-0223, an investigational sublingual form of riluzole for treatment of ALS. The therapy is a novel formulation that is administered sublingually and in December 2016 was granted orphan drug designation by the FDA. The new drug application submission is backed by data from multiple studies and clinical trials that evaluated the bioequivalence of BHV-0223 to riluzole tablets as well as the safety and tolerability of BHV-0223.
The main data from the clinical program, designed to demonstrate pharmacokinetic equivalence of sublingual BHV-0223 compared to oral riluzole, confirmed that sublingual administration of BHV-0223 (40 mg) achieved similar blood exposures to orally ingested riluzole (50 mg) but with a 20% lower total daily drug burden.
If approved, this therapy would become the only formulation of riluzole that doesn’t require swallowing tablets or liquids, offering an important delivery alternative for the standard-of-care treatment of ALS.
NeurologyLive sat with Stephen Silberstein, MD, of Thomas Jefferson University, to discuss the importance of lifestyle modifications for patients suffering from chronic migraine. Let’s take a look.
For more direct access to expert insight, head to neurologylive.com. This has been Neurology News Network. Thanks for watching.