Akums Drugs & Pharmaceuticals, a leading contract manufacturing drug firm, announced on Tuesday that it has received approval from the Drug Controller General of India (DCGI) for its formulation designed to treat certain types of seizures in patients with epilepsy. The approved product, Perampanel Oral Suspension, has been granted the status of adjunctive therapy for the treatment of partial-onset seizures (POS) with or without secondarily generalized seizures, as well as primary generalized tonic-clonic (PGTC) seizures in patients aged 12 years and older suffering from epilepsy within the country.
In a statement released by the company, it was revealed that the newly approved formulation is a bioequivalent version of the US Food and Drug Administration (USFDA)-approved Fycompa (perampanel) Oral Suspension. This signifies that Perampanel Oral Suspension has been proven to be comparable to Fycompa in terms of its safety, efficacy, and overall therapeutic effect.
Epilepsy is a neurological disorder characterized by recurring seizures, which are caused by abnormal electrical activity in the brain. It affects millions of people worldwide, and India is no exception to this medical challenge. Partial-onset seizures are one of the most common types of seizures experienced by individuals with epilepsy, where the seizure activity originates in a specific part of the brain and may or may not spread to other areas. Generalized tonic-clonic seizures, on the other hand, involve a widespread electrical discharge throughout the brain, leading to loss of consciousness and convulsions. These seizures can be particularly debilitating and have a significant impact on the quality of life for those affected.
The approval of Perampanel Oral Suspension offers new hope for patients suffering from epilepsy in India. By providing an adjunctive therapy option, it aims to improve seizure control and ultimately enhance the overall management of the condition. Adjunctive therapy refers to the use of additional medications alongside the patient’s existing treatment regimen to further reduce the frequency and severity of seizures.
Akums Drugs & Pharmaceuticals has a strong reputation in the pharmaceutical industry for its expertise in contract manufacturing. The company is known for its commitment to quality, innovation, and compliance with regulatory standards. With the approval of Perampanel Oral Suspension, the company has demonstrated its dedication to addressing the unmet medical needs of epilepsy patients in India.
Perampanel, the active ingredient in the oral suspension, acts as an antagonist of the AMPA (alpha-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid) glutamate receptor. By blocking these receptors, it helps to regulate the abnormal electrical activity in the brain that leads to seizures. The oral suspension form provides a convenient and easily administered option for patients, particularly those who may have difficulty swallowing tablets or capsules.
The DCGI approval is a significant milestone for Akums Drugs & Pharmaceuticals, as it allows the company to introduce a high-quality, locally manufactured alternative to the USFDA-approved Fycompa. This not only enhances accessibility to the medication but also contributes to the growth of the domestic pharmaceutical industry. By promoting indigenous manufacturing capabilities, India can reduce its dependence on imported drugs and strengthen its position as a self-sufficient pharmaceutical hub.
Akums Drugs & Pharmaceuticals plans to launch Perampanel Oral Suspension in the Indian market in the near future. The availability of this formulation will provide healthcare professionals with a valuable therapeutic option for managing epilepsy seizures, ultimately improving the lives of patients who have been grappling with the condition. The company’s commitment to quality, coupled with its extensive manufacturing experience, ensures that patients can trust the safety and efficacy of Perampanel Oral Suspension.
