US OK for Teva’s fentanyl patch

By Gareth Macdonald

- Last updated on GMT

Related tags: Fentanyl

US FDA approval for Teva’s transdermal fentanyl patch ushers the Israeli generics giant into the potentially lucrative but often problematic chronic pain therapy sector.

Fentanyl is an analgesic used to treat pain associated with long-term illnesses including cancer, bone injuries, severe back pain, neuropathy, arthritis. The drug is often administered via sustained delivery technologies that release it gradually over 24 to 48 hours.

The US market alone for such products, which includes both branded and generic formulations, was worth $1.2bn in the 12 months to June 2008, according to IMS health.

Fentanyl’s considerable potency, it is around 80 times more powerful than morphine, means that overdoses can be fatal. In recognition of this risk regulatory agencies worldwide strictly control its use in pharmaceutical products.

As a result, withdrawals are common. In the last 12 months both Ortho McNeil and Actavis have recalled fentanyl patches from US shelves after the Food and Drug Administration (FDA) identified problems with manufacture that could result in overdose.

Caution over fentanyl use is employed throughout the global healthcare sector. Earlier this month for example, Ortho McNeil parent Johnson & Johnson withdrew Ionsys in 11 countries in Europe after it emerged that a manufacturing defect could allow hospitalised patients to self administer.

Despite the significant challenges that the fentanyl market presents, Teva is bullish about its prospects. The firm said that it has initiated commercial launch of its patch in the US and has already released the first shipments.

Teva's product was developed and manufactured by Nitto Denko’s Florida-headquartered subsidiary Aveva Drug Delivery Systems, which is a specialist developer of drugs in adhesive technologies.

The system uses a proprietary matrix design which incorporates the drug into the adhesive. It is indicated for the management of persistent moderate to severe chronic pain that requires continuous, around-the-clock opioid administration.

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