Approval of ‘hybrid generic’ PecFent (fentanyl) in EU

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Approval of ‘hybrid generic’ PecFent (fentanyl) in EU

Generics/News | Posted 09/07/2010 0 Post your comment

On 25 June 2010, Archimedes Pharma (Archimedes) announced that it had received a positive opinion from the CHMP of the EMA for its ‘hybrid generic’ PecFent (fentanyl).

In its June 2010 hearing, the committee said the hybrid generic contains a known active substance (fentanyl), but is presented in a new pharmaceutical form – a nasal spray.

The medicines Actiq lozenges and Effentora buccal tablets are the reference products for PecFent, both of which contain fentanyl.

Fentanyl is a phenylpiperidine derivative – a pure opioid agonist, which acts primarily through interaction with receptors located in the brain, spinal cord and smooth muscle to produce its analgesic effect.

PecFent is indicated for the treatment of breakthrough cancer pain – sudden, unpredictable episodes of intense pain that occur despite background pain medication.

President and CEO of Archimedes, Mr Jeffrey Buchalter, stated that "this is a defining moment for Archimedes Pharma. Breakthrough cancer pain is a poorly served indication and affects up to 95% of all cancer patients with pain”.

PecFent is an aqueous fentanyl citrate solution using Archimedes Pharma’s proprietary PecSys technology to allow fentanyl to be retained on the nasal mucosa and is designed to produce rapid, but controlled, absorption into systemic circulation.

Archimedes also submitted a New Drug Application (NDA) for PecFent with the US FDA in August 2009 and is in the process of establishing its own US commercial organisation to market the drug in the US once approved.

Reference:

Archimedes Pharma News, Archimedes Pharma Receives CHMP Positive Opinion for PecFent® for the Treatment of Breakthrough Cancer Pain, 25 June 2010