Akums, a Contract Development and Manufacturing Organisation (CDMO), on Tuesday, announced that the Drug Controller General of India (DCGI) has approved Perampanel Oral Suspension.
According to the company’s press statement, this 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.
According to a report by the World Health Organisation (WHO) around 50 million people worldwide have epilepsy, making it one of the most common neurological diseases globally. An estimated 5 million people are diagnosed with epilepsy every year. India has more than 10 million patients with epilepsy, i.e., 20% out 50 million worldwide.
“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. 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,” Sanjeev Jain, Jt. Managing Director, Akums Drugs & Pharmaceuticals said in a statement.
The newly approved Perampanel Oral Suspension formulation is now available in 100mL bottles, with a strength of 0.5mg/mL. The packaging includes a convenient oral dosing applicator ensuring accurate dosage administration and enhancing patient compliance.
