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FDA Approves Tiglutik

ITF Pharma Announces FDA Approval of Tiglutik (riluzole) Oral Suspension for the Treatment of Amyotrophic Lateral Sclerosis (ALS)

BERWYN, Pa., Sept. 6, 2018 /PRNewswire/ -- ITF Pharma, a U.S.-based specialty pharmaceutical company and a subsidiary of Italfarmaco, a privately-held European specialty pharmaceutical company, committed to investing in and commercializing impactful medicines in therapeutic areas with unfulfilled needs, announced today that the U.S. Food and Drug Administration (FDA) has approved Tiglutik (riluzole) oral suspension for the treatment of amyotrophic lateral sclerosis (ALS). Tiglutik is the first and only easy-to-swallow thickened riluzole liquid for ALS and is administered twice daily via an oral syringe.

Paolo Bettica, MD, PhD, vice president, research and development of Italfarmaco, commented:

The approval of Tiglutik is based on bioavailability studies comparing oral riluzole tablets to Tiglutik oral suspension. The most common side effects of Tiglutik are consistent with the established clinical profile of riluzole and include oral hypoesthesia, asthenia, nausea, decreased lung function, hypertension and abdominal pain. While riluzole's mechanism of action is not fully understood, in clinical studies it has been shown repeatedly to modulate glutamate neurotransmission by inhibiting both glutamate release and postsynaptic glutamate receptor signaling.

Tiglutik was approved under FDA fast-track designation, which expedites the review of drugs that have the potential to treat serious conditions and fill an unmet medical need. Tiglutik has received orphan drug designation from the FDA.

About Amyotrophic Lateral Sclerosis (ALS)

Amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig's disease, is a progressive, ultimately fatal neurodegenerative disease, marked by a gradual degeneration of nerve cells of the central nervous system that control voluntary muscle movement.i According to the ALS Association and based on U.S. population studies, a little over 5,000 people in the U.S. are diagnosed with ALS each year. It is estimated that more than 20,000 Americans have the disease at any given time. The incidence of ALS increases with age, typically starting in the 40s and continuing until around the age of 80. However, ALS can occur in people in their 20s and 30s.ii In ALS, the degeneration of motor neurons is characterized by muscle weakness, typically impacting arms and legs, speech, swallowing and breathing. Impairment of swallowing (dysphagia) is a feature of ALS resulting from weakness or spasticity of muscles affecting the tongue, lips, palate, jaw, pharynx, larynx and upper trunk.i

About Tiglutik (riluzole) Oral Suspension

Tiglutik (riluzole) oral suspension is indicated for the treatment of amyotrophic lateral sclerosis (ALS). Tiglutik is the first and only easy-to-swallow thickened riluzole liquid for ALS, and is administered orally twice-daily via a syringe. In clinical studies, the most common side effects of Tiglutik were oral hypoesthesia, asthenia, nausea, decreased lung function, hypertension, and abdominal pain. These are not all of the possible side effects that you may experience with Tiglutik. Talk to your doctor if you have any symptoms that bother you or do not go away.

Indication

Tiglutik (riluzole) is a prescription medicine for the treatment of amyotrophic lateral sclerosis (ALS).

Important Safety Information

You should not take Tiglutik if you are allergic to any of its ingredients.
Tiglutik can cause liver injury, including death. Your doctor should do blood tests to check your liver function before and during your treatment and may stop treatment with Tiglutik if liver function is not normal. Contact your doctor immediately if you have unexplained nausea, vomiting, abdominal pain, fatigue, anorexia, or jaundice and/or dark urine
Call your doctor immediately if you have a fever, cough, or difficulty in breathing while taking Tiglutik.
If you miss or skip a dose of Tiglutik, do not take any extra doses to make up for those you missed, but take your prescribed dose at the next regularly scheduled time.
The most common side effects of Tiglutik that occurred during medical studies were numbness/tingling around the mouth, weakness, nausea, decreased lung function, high blood pressure, and abdominal pain. If any side effects become troublesome, contact your doctor.
Be sure to tell your doctor and pharmacist about all other health conditions you have and all medicines you are taking, including nonprescription products and vitamins. If you have questions, please talk to your doctor.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-332-1088.

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