FDA clears novel ALS drug

September 11, 2018

FDA cleared the first and only easy-to-swallow liquid drug to treat amyotrophic lateral sclerosis (ALS).

FDA cleared the first and only easy-to-swallow liquid drug to treat amyotrophic lateral sclerosis (ALS).

Riluzole (Tiglutik, ITF Pharma) oral suspension is administered twice daily via an oral syringe. It will be available in the United States in mid-October via ITF Pharma’s specialty pharmacy partner, Foundation Care.

Related: Costly new ALS treatment approved

“Until now, riluzole has only been available in a tablet form, which presents challenges when swallowing problems develop. In fact, more than 80% of ALS patients develop disease-related dysphagia, rendering the oral administration of riluzole tablets virtually impossible,” Denny Willson, CEO of ITF Pharma, told FormularyWatch.

Manipulation of a solid oral drug-such as crushing the tablets to aid administration-increases the likelihood of medication errors and promotes the possibility of incorrect and incomplete dosing, changes in drug performance and overall safety concerns, Willson added.

Related: FDA clears first chronic drooling treatment

The price of the medication will be in line with other branded therapies on the market for ALS, according to Willson. “We will determine the price of Tiglutik based on a variety of factors, including the value of Tiglutik associated with the benefits it offers to patients as well as their caregivers, health insurers and the healthcare system/society as a whole, patient affordability and patient access to care driven by payer coverage.”

Payers and PBMs have been receptive to early engagement on Tiglutik pricing, Willson added. “ITF Pharma is committed to supporting the ALS community and to helping people living with ALS find affordable access to Tiglutik,” he said.

Read more: Top 3 new drugs to treat rare diseases