Tiglutik (riluzole oral suspension) is a U.S. Food and Drug Administration (FDA)-approved medication for the treatment of amyotrophic lateral sclerosis (ALS). It is marketed by ITF Pharma. The medication received FDA approval in September 2018.

Tiglutik is a liquid oral formulation of riluzole, which so far has only been available as tablets under the brand name Rilutek. Because ALS patients have difficulties swallowing, the administration of tablets can be difficult. Tiglutik is administered with an oral dosing syringe, which is more comfortable for patients.

Tiglutek was approved under the FDA’s fast track designation, which helps speed up the review process of a new medication. It was also designated an orphan drug by the FDA.

In the U.K., a liquid riluzole formulation exists under the name Teglutik marketed by Martindale Pharma. It has been available since 2015.

How Tiglutik works

It is thought that an excess of the neurotransmitter glutamate may cause nerve damage in ALS patients. Neurotransmitters are signaling molecules that nerve cells use to communicate with each other. A nerve cell releases a neurotransmitter that binds to receptors on a neighboring nerve cell. Soon after, the neurotransmitter usually gets cleared from the space between nerve cells, which then become ready to transmit new signals. If the neurotransmitter is not removed, the overstimulation can damage the nerve cells.

The exact mechanism of action of riluzole in ALS is not well understood. It is thought that it may inhibit the release and signaling of glutamate and therefore reduce the damage caused by glutamate and slow the progression of ALS.

Tiglutik studies

The approval of Tiglutik was based on data from bioavailability studies comparing riluzole tablets (Rilutek) with Tiglutik oral suspension.

Study participants were healthy male volunteers. Measurements were performed after single oral administrations of 25 to 300 mg riluzole and after multiple-dose oral administrations of 25 to 100 mg riluzole twice daily, in both tablet and oral suspension form.

The results showed that Tiglutik was more rapidly absorbed than Rilutek; the maximal concentration of riluzole that was measured in the blood was about 20 percent higher with Tiglutik compared to Rilutek.

The most common side effects of Tiglutik were similar to Rilutek and included a reduced sense of touch, a lack of energy and strength, nausea, decreased lung function, high blood pressure, and abdominal pain.

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