Flector Tissuegel®,  IBSA’s patch containing 1.3% epolamine salt of diclofenac (corresponding to 1% of diclofenac sodium), has been approved by the FDA for the treatment of acute pain due to minor strains, sprains and contusion. The USA marketing authorisation enlightens another major achievement and a further confirmation of the expansion trend of the company. Since its initial approval by Swiss  regulatory authorities in 1993, Flector Tissugel® was approved for sale in other 39 countries throughout the world, including the EU. IBSA’s patented epolamine salt of diclofenac displays a high solubility profile both in water and oily solvents and it’s specifically developed in order to achieve a significant release of active from the patch and subsequent absorption through the skin. The application to the injured area twice a day performs a local analgesic and anti-inflammatory effect with minor systemic exposure to diclofenac.

Due to these properties Flector Tissuegel® has already established market leadership in its segment, either as prescription or as OTC product according to local authorisations in many of the countries where it was introduced, and candidates as a leading product also in the US market where it will be available under medical prescription.

IBSA is a Swiss-based international pharmaceutical company involved in the development, manufacturing and marketing of proprietary drugs for human use. Besides NSAIDs, other company’s franchises include osteoarthritis, endocrinology, dermatology and fertility hormones.

Flector Tissugel® is a 10x14 cm adhesive patch containing 180 mg of diclofenac epolamine applied on a non-woven felt backing and covered with a polypropylene release liner. The product is intended for use under medical control and according to the specifications of the marketing authorisation, where available.