Exservan, Riluzole Oral Film for ALS, Now Available in US

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by Marta Figueiredo PhD |

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Exservan, the first oral film formulation of riluzole for treating amyotrophic lateral sclerosis (ALS), has been launched in the United States, its developer, Mitsubishi Tanabe Pharma America (MTPA), has announced.

Rapidly dissolved when placed on top of the tongue, Exservan — specifically developed to help meet the needs of patients with swallowing difficulties, a common ALS disease symptom — was approved in the U.S. in November 2019.

“Patients are the primary focus of our work as we try to make a difference, and we are pleased to bring this new option to those suffering from this devastating and progressive disease,” Atsushi Fujimoto, MTPA’s president, said in a press release.

“People with ALS can develop difficulty swallowing, affecting how certain medications are administered,” Fujimoto said.

The therapy is available through a single specialty pharmacy, PANTHERx Rare, with prescription and enrollment forms submitted by the patient’s healthcare provider. Patients will then be contacted by the specialty pharmacy to review insurance benefits and product dispensing.

According to MTPA, patients may be considered for eligibility for Exservan’s out-of-pocket assistance program.

This process is open to ALS patients prescribed Exservan through federal institutions, such as the Department of Veterans Affairs and the Department of Defense, and through certain integrated delivery networks. These networks should obtain the therapy with other medications through healthcare providers.

For more information about Exservan, patients and healthcare providers can call 1-855-457-6968 to speak with a JourneyMate specialist. PANTHERx also can be contacted at 1-855-743-9275.

Exservan is an oral film formulation of riluzole, whose tablet oral formulation was the first treatment to be approved for ALS in the U.S., in 1995. Riluzole tablets, developed by French pharmaceutical Rhone-Poulenc Rorer, are now sold as Rilutek by Sanofi. In recent years, several generic versions, which usually sell for lower prices, have become available. Riluzole also is sold in a liquid form as Tiglutik by ITF Pharma.

While riluzole’s exact mechanism of action is not fully understood, it is thought to block the release of glutamate, a brain messenger molecule that is overly produced in ALS, from nerve cells.

Too much glutamate can weaken and kill the nerve cells controlling voluntary muscle movements, leading to muscle weakness and wasting. Riluzole treatment is associated with prolonged survival and studies suggest that it may be most effective in patients with more advanced disease.

Developed by Aquestive Therapeutics, Exservan uses its PharmFilm innovative medicine delivery technology. Each orange thin film contains 50 mg of riluzole and is placed on top of the tongue to rapidly dissolve without liquids or food. Treatment should be taken twice a day at least one hour before or two hours after a meal.

Exservan’s U.S. approval was based on data from previous trials showing that the therapy had an equivalent pharmacokinetics profile to Rilutek, meaning that its movement into, through, and out of the body was similar. It also was found to have a good safety profile. In the trials, Exservan was shown to deliver a similar amount of riluzole as Rilutek tablets throughout the bloodstream.

The therapy’s most common side effects include numbness in the mouth or tongue, muscle weakness, nausea, lung problems, high blood pressure, and abdominal pain. Serious adverse events such as liver and lung problems, and low counts of white blood cells, also can occur.

Gary L. Pattee, MD, a neurologist and ALS specialist based in Lincoln, Nebraska, said that many people living with ALS “have or will experience difficulty swallowing some medications” and that some have to crush tablets to take a prescription drug.

“Alternative formulations of riluzole can play an important role in the treatment plan for people with ALS, including those who have difficulties swallowing some medications,” Pattee said, adding that Exservan’s launch is “exciting news for the ALS community.”

Early this year, MTPA, which also is the developer of the ALS treatment Radicava (edaravone), acquired Exservan’s commercial rights in the U.S. from Aquestive, which remains the therapy’s sole manufacturer and supplier.

In the European Union, where the therapy is not yet approved, Zambon Pharma is responsible for the development and commercialization of Exservan, after entering a licensing agreement with Aquestive in 2019.