Akums Drugs and Pharma gets DCGI approval for anti-epilepsy drug, perampanel oral suspension

Akums Drugs and Pharmaceuticals, a major contract development and manufacturing organisation (CDMO) in the country, announced that the Drugs Controller General of India (DCGI) has approved an epilepsy treatment drug perampanel oral suspension. The drug is a bioequivalent formulation to the US FDA approved Fycompa oral suspension from Catalyst Pharmaceuticals. The 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, said Akums Drugs and Pharmaceuticals in its announcement. "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, joint managing director, 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, joint managing director, 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." 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. The newly approved perampanel oral suspension formulation is now available in 100mL bottles, with a strength of 0.5mg/mL. The packaging includes an oral dosing applicator ensuring accurate dosage administration and enhancing patient compliance. The company expects that the drug approval strengthens its position in the central nervous system (CNS) category.

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