FDA grants orphan drug designation for NRL-1 to treat repetitive seizures

Neurelis Inc. has received an orphan drug designation from the FDA for its intranasal diazepam program for the treatment of acute repetitive seizures in children and adults with epilepsy, according to a press release.

The company’s proprietary formulation of diazepam, intranasal diazepam, or NRL-1, is delivered through a nasal sprayer that is already marketed in the United States, and is intended for patients who already require intermittent use of diazepam to control seizures

The orphan drug designation comes after clinical trial results that demonstrated NRL-1 was well-tolerated, had low variability between doses and had high bioavailability, according to the release.

More than 2.7 million adults and children in the United States have epilepsy, and 30% to 40% of these individuals receive oral therapy; however their condition remains uncontrolled, putting them at risk for acute breakthrough seizures, according to the release.

“We are pleased to have received orphan drug designation from the FDA based on the potential clinical benefit of NRL-1 to patients who experience acute repetitive seizures. Pediatric, adolescent, adult patients and their caregivers desire an effective, reliable and well-tolerated treatment alternative to either rectal diazepam or an ED visit. We are committed to bringing NRL-1 to the epilepsy community for this very purpose. This designation is an important milestone to achieve as we continue the clinical development program for NRL-1,” Craig C. Chambliss, president and CEO of Neurelis, said in the press release.