A Dose of Success: Marksans Pharma Receives UK Approval for Gabapentin Innovation

Marksans Pharma's wholly owned subsidiary has attained an important regulatory milestone with marketing authorization for Gabapentin 50 mg/ml Oral Solution-a flagship product for the treatment of epilepsy and neuropathic pain. The approval, made by the UK's Medicines and Healthcare products Regulatory Agency (MHRA), adds to the company's foothold in high-growth central nervous system (CNS) therapeutics.

 

New Authorization:

Marksans Pharma's facility has received marketing approval for Gabapentin 50 mg/ml Oral Solution, allowing the company to market and sell this significant therapy in the UK and possibly other regulated markets.

 

Therapeutic Indications:

Gabapentin oral solution is used as adjunctive treatment for partial seizures (with or without secondary generalization) in adult and pediatric patients aged 6 years and older and for the treatment of peripheral neuropathic pain, including diabetic neuropathic pain and post-herpetic neuralgia in adults.

 

Market Opportunity:

The oral solution format is particularly prized for use among pediatric, geriatric, and dysphagic patients unable to swallow tablets or capsules, which broadens the patient pool and meets clinical needs not yet being met.

 

Strategic Growth:

The approval supports Marksans Pharma's plan to extend the diversification of its portfolio in CNS drugs and its positioning in the UK and Europe markets with recent authorizations for additional oral solutions.

 

Manufacturing and Expansion

The drug will be produced at Marksans Pharma's UK plant, promoting local jobs and export opportunity. The firm's clean regulatory record and strengthening pipeline have driven strong stock performance and increasing investor optimism.

 

Sources: Marksans Pharma Press Release, DailyMed, Medicines.org.uk