The market for novel formulations of baclofen is heating up. Weeks after Saol Therapeutics won approval for its strawberry-flavored oral granules, Azurity Pharmaceuticals has received FDA authorization for an oral suspension aimed at the same piece of the market.
Physicians prescribe baclofen to treat muscle spasms and stiffness in patients with multiple sclerosis and spinal cord injuries. However, the established spinal canal delivery and tablet formulations have certain limitations. Tablets are unsuitable for people who have difficulty swallowing and injections, while getting more of the drug to target sites and addressing some side effects, can be painful.
Over the past two months, two new options have won approval in the U.S. Azurity is the latest entrant to the market, winning FDA approval for a grape-flavored oral suspension formulation of baclofen for use in the treatment of spasticity resulting from multiple sclerosis.
The product, branded Fleqsuvy, is available in 120-ml or 300-ml bottles at a concentration of 5 mg per ml. Azurity is pitching Fleqsuvy as the most concentrated FDA-approved oral liquid baclofen formulation. As Azurity sees things, the concentration of Fleqsuvy is beneficial when treating patients who struggle to swallow as it allows for the lowest volume to be prescribed to patients.
Azurity CEO Amit Patel set out the benefits in a statement. “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 said.
The approval comes two months after FDA authorized Saol’s strawberry-flavored oral baclofen granules. Saol’s granules, which it sells as Lyvispah, are available in 5-mg, 10-mg and 20-mg packs and are approved for administration with or without water, with soft foods and with enteral feeding tubes.