Azurity Pharmaceuticals Inc. announced that the US Food and Drug Administration (FDA) approved Fleqsuvy™ for the treatment of spasticity in patients with multiple sclerosis (MS), as published in their news release. Their oral baclofen suspension is also approved for the treatment of spinal cord injuries and other spinal diseases.
Nearly 1 million people have MS in the US and spasticity is estimated to affect roughly 67% of them, according to the press release.
“The approval of [Fleqsuvy] represents our commitment to providing innovative alternative formulations that address individualized patient needs,” Amit Patel, chairman, and chief executive officer of Azurity Pharmaceuticals said.
Fleqsuvy is a grape-flavored suspension of baclofen concentrated at 25 mg per 5 mL (5 mg/mL). This makes it the most concentrated baclofen suspension currently approved by the FDA. A high concentration allows for it to be administered at lower volumes than other suspensions.
This may be an important consideration for patients experiencing dysphagia, who may have trouble swallowing pills or large volumes of liquid. Dysphagia is estimated to affect roughly 43% of patients with MS and 16%-30% of patients with spinal cord injuries.
Read more about MS complications
“The clinical profile of [Fleqsuvy] allows for a tailored and flexible approach to dosing for patients suffering from spasticity, a debilitating symptom that may impact daily functioning,” Patel added.
Fleqsuvy is a gamma-aminobutyric acid agonist intended for use to combat flexor spasms with concomitant pain, clonus, and muscle rigidity in patients. It is not indicated to treat skeletal muscle spasms resulting from rheumatoid disorders.
The maximum approved dose for Fleqsuvy is 80 mg per day. Drowsiness, dizziness, and weakness are the most commonly reported adverse reactions (up to 15% or more) in patients. Since Fleqsuvy is concentrated, it is recommended that patients gradually increase doses over time.
Azurity Pharmaceuticals is a privately held company with products that span the cardiovascular, endocrine, neurological, gastrointestinal, institutional, and orphan markets. It also has a number of other new products currently under review.
Azurity Pharmaceuticals, Inc. announces FDA approval of Fleqsuvy. News Release. Azurity Pharmaceuticals; February 7, 2022.
FleqsuvyTM (baclofen oral suspension) [prescribing Information]. Azurity Pharmaceuticals, Inc.; 2022. Accessed February 8, 2022.