Akums bags DCGI approval for Perampanel Oral Suspension
The suspension holds the potential to play a key role in improving seizure management, particularly in poorly controlled adults and adolescents
Akums announced the first-time approval of Perampanel Oral Suspension by the Drug Controller General of India (DCGI). This groundbreaking approval allows Perampanel Oral Suspension to serve as adjunctive therapy for the treatment of partial-onset seizures (POS) with or without secondarily generalised seizures, as well as primary generalised tonic-clonic (PGTC) seizures in patients with epilepsy aged 12 years and older in the country. The Perampanel Oral Suspension is a bioequivalent formulation to the US FDA-approved FYCOMPA (perampanel) Oral Suspension.
"We are excited about the approval of Perampanel Oral Suspension, as it provides another treatment option for patients with epilepsy who may have difficulty swallowing tablets or prefer liquids," said Sanjeev Jain, Jt MD, Akums Drugs & Pharmaceuticals. "The development of this new formulation underscores Akums' unwavering commitment to advancing epilepsy care and making significant contributions to address the diversified needs of epilepsy patients and their families."
The successful management of partial-onset seizures remains a significant challenge for many epilepsy patients and the incidence of uncontrolled seizures remains alarmingly high, despite the availability of existing treatments," explained Sandeep Jain, Jt. MD, Akums Drugs & Pharmaceuticals. "Perampanel represents an important new option for the treatment of partial-onset epilepsy, and it holds the potential to play a key role in improving seizure management, particularly in poorly controlled adults and adolescents."
The newly approved Perampanel Oral Suspension formulation is now available in 100 mL bottles, with a strength of 0.5mg/mL. The packaging includes a convenient oral dosing applicator ensuring accurate dosage administration and enhancing patient compliance.