In addition to those with MS, the approval also indicates the formulation for the treatment of patients with spinal cord injuries and other spinal cord diseases.
The FDA has approved baclofen oral suspension (Fleqsuvy; Azurity Pharmaceuticals) Concentrated Formulation, in doses of 25 mg per 5 mL (5 mg/mL), for the treatment of spasticity resulting from multiple sclerosis (MS), Azurity announced. The approval also permits the use of the medication for the treatment of patients with spinal cord injuries and other spinal cord diseases.1
"The approval of Fleqsuvy represents our commitment to providing innovative alternative formulations that address individualized patient needs,” Amit Patel, chairman and CEO, Azurity Pharmaceuticals, said in a statement.1 “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.”
The oral suspension formulation of baclofen is intended to treat spasticity in patients with MS; specifically, relief of flexor spasms and concomitant pain, clonus, and muscle rigidity. The medication is not indicated for the treatment of skeletal muscle spasms resulting from rheumatic disorders.
This is the most concentrated FDA-approved oral liquid formulation of baclofen, which allows for the lowest volume to be prescribed and offers benefit for those with dysphagia. The liquid formulation offers an additional benefit for patients with MS who prefer a liquid formulation or have trouble swallowing pills.
In addition to the oral formulation of baclofen, in February 2020, the FDA granted market approval to Flowonix Medical’s Prometra II Programmable Pump System for use with intrathecal baclofen for patients with severe spasticity of cerebral or spinal origin. The device offers a pressure-driven, valve-gated delivery mechanism that allows for novel programming modes of intermittent flow followed by periods of no flow. The indication expanded Flowonix’s previous market entry in November 2019, when the Prometra II 40 mL pump was introduced.2
Azurity, which acquired Eton Pharmaceuticals neurology portfolio in February 2021, is currently awaiting an FDA decision on zonisamide oral suspension for the treatment of partial seizures in patients with epilepsy. The approval was not announced on the set Prescription Drug User Fee Act date of January 29, 2022, which is now anticipated to come before the end of Q1 2022. In July 2020, Eton announced the submission of the new drug application (NDA) to the FDA for zonisamide oral suspension, addressing an unmet need for a liquid formulation of the treatment. Already widely used in capsule form to treat partial seizures, the liquid formulation provides an option for patients with dysphagia, as well as those who require precision dosing.3,4
The third drug in the portfolio, an oral formulation of topiramate 25 mg/mL, marketed as Eprontia, was approved in November 2021 for treatment of epilepsy and migraine, which is the first and only liquid formulation of the medication to receive a green light. Eprontia can now be used orally as a monotherapy to treat partial-onset or primary generalized tonic-clonic seizures in patients 2 years of age and older, as an adjunctive therapy for treatment of partial-onset seizures, primary generalized tonic-clonic seizures or seizures associated with Lennox-Gastaut syndrome in the same age group, and as a preventive treatment of migraine for patients aged 12 years and older.5