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Patent including formula to improve Contrave tolerability gets go-ahead

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Orexigen Therapeutics received a notice of allowance from the US Patent and Trademark Office for an application that covers the sustained-release formulation of naltrexone, according to a statement from the company.

The formula is designed to improve the drug tolerability for combination therapy naltrexone HCI-bupropion HCI extended release (Contrave) as a treatment for adults with obesity, according to the statement.

The decision extends the patent protection — currently grouped with Weber/Cowley patents for the existing composition of the drug and methods of administration to treat obesity, expected to expire in 2024/2025 — to March 2028.

A counterpart application to the Weber/Crowley patent, issued in the European Patent Office, provides protection for naltrexone HCI-bupropion HCI prolonged release (Mysimba) in registered countries, according to the release; this is one of several international applications.

The combination drug is designed for use as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with a BMI ≥30 kg/m2 or ≥27 kg/m2 with at least one weight-related comorbid condition including hypertension, type 2 diabetes or dyslipidemia.