Exservan, Riluzole as Oral Film, Soon Available in US via PANTHERx

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by Forest Ray PhD |

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Note: This story was updated June 30, 2021, to clarify that Exservan is placed on top of the tongue, not under it.

Specialty pharmacy services for Exservan (riluzole), a twice-daily film that dissolves when placed on the tongue and approved to treat amyotrophic lateral sclerosis (ALS), will be exclusively provided in the U.S. by PANTHERx Rare Pharmacy, and soon be made available.

The announcement comes in the heels of an agreement between Mitsubishi Tanabe Pharma America (MTPA) — the sole U.S. manufacturer and supplier of Exservan — and the specialty pharmacy, which serves people with rare diseases.

Services available to patients with a prescription, and upon enrollment, include a review and summary of their insurance benefit options, and information related to eligibility for Exservan’s Out-of-Pocket Assistance Program.

“PANTHERx prides itself on being focused on people living with the implications of rare disease,” Rob Snyder, president of PANTHERx, said in a press release. “We hope our extensive experience will positively impact the members of the ALS community that we aim to serve through our dispensing of Exservan.”

Exservan was approved by the U.S. Food and Drug Administration (FDA) in 2019 and, according to MTPA, will be available to patients nationwide by month’s end.

Exservan, along with other riluzole-containing medications such as Rilutek, a tablet with generic options, and Tiglutik, a liquid, is meant to slow the advancement of disease symptoms. Although the drug’s exact mechanism of action is not fully understood, it is thought to work by blocking the action of the chemical messenger glutamate.

Too much glutamate can weaken and kill the nerve cells controlling voluntary muscle movements. Without nerves telling them to contract, muscles progressively atrophy, or waste away, leading to the cramps, slurred speech, spasticity (muscle tightness or rigidity), trouble swallowing, and other symptoms characteristic of ALS.

The swallowing challenges that many patients experience can make taking oral medications, such as pills, complicated. Exservan, an oral film with a 50 mg riluzole dose that dissolves in the mouth without water, aims to make taking riluzole easier, avoiding the need to be swallowed.

The medication was developed by Aquestive Therapeutics, which licensed MTPA to manufacture and commercialize it in the United States. MTPA in turn, has granted PANTHERx exclusive rights to provide specialty pharmacy services for the medication.

“As we explored options for specialty pharmacy partners for the distribution of EXSERVAN, it was important to find an organization with specific knowledge and experience that could best support the ALS community,” said Kevin O’Brien, MTPA’s vice president of market access.

“PANTHERx is able to deliver on both fronts, in addition to also having an unwavering dedication to patients,” he added.

Riluzole was the first ALS treatment to be approved by the FDA, in 1995. Studies suggest it may be most effective in people with more advanced disease.