The US Patent and Trademark Office (USPTO) has issued US patent No. 8,658,663, entitled “method of treating thermoregulatory dysfunction with paroxetine” to Noven Pharmaceuticals, Inc. This method of use patent covers the company’s Brisdelle (paroxetine) capsule 7.5 mg, for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause, commonly referred to as hot flashes.

The patent, listed recently in the US FDA’s Orange Book, provides additional protection until April 2029, six years beyond the last to expire of the other listed Brisdelle patents.

Brisdelle is the first and only non-hormonal treatment specifically studied and US FDA approved for moderate to severe VMS associated with menopause. Although it has the same ingredient as the antidepressant paroxetine, Brisdelle is a lower dose (7.5 mg) that is not approved to treat depression or any other psychiatric condition. The method of use patent covers the use of paroxetine at this lower dose in treating moderate to severe VMS associated with menopause as a novel approach.

Brisdelle (paroxetine) capsule 7.5 mg, was approved by the US FDA in June 2013 for the treatment of moderate to severe VMS associated with menopause, commonly referred to as hot flashes. Prior to the approval of Brisdelle, hormone therapy was the only US FDA approved treatment for VMS. Many women are unable or unwilling to take hormone therapy to treat their VMS associated with menopause, often leaving symptoms untreated.

Brisdelle was studied in one phase 2 and two phase 3 randomized, placebo-controlled trials in 1,276 women with moderate to severe VMS associated with menopause and was clinically proven to reduce frequency and severity of these symptoms. Brisdelle has similar warnings and precautions to the higher doses of paroxetine used to treat a number of psychiatric disorders, including a Boxed Warning about Suicidal Thoughts or Behaviours. The most common adverse reactions, defined as those experienced by at least 2 per cent of patients taking Brisdelle compared to placebo, were headache (6.3 vs. 4.8 per cent), fatigue/malaise/lethargy (4.9 vs. 2.8 per cent) and nausea/vomiting (4.3 vs. 2.3 per cent).

Brisdelle (paroxetine) capsules is a prescription medicine used to reduce moderate to severe hot flashes associated with menopause.

Brisdelle and Pexeva are registered trademarks of Noven Therapeutics, LLC.

Noven Pharmaceuticals, Inc. is a specialty pharmaceutical company engaged in the research, development, manufacturing, marketing and sale of prescription pharmaceutical products.