ProStrakan extend deal with Orexo for Rapinyl

ProStrakan have extended its existing European licensing agreement for Rapinyl with its Swedish partner Orexo to include North America.

Akela Pharma to repeat Fentanyl TAIDUN tests at request of FDA

Akela Pharma have announced that it will repeat required inhalation toxicology studies at the request of the FDA before commencing long term safety Phase III trials

ProStrakan receives positive EMEA opinion for Rapinyl (Abstral) in cancer pain

The EMEA has issued a positive opinion for ProStrakan’s sublingual fentanyl product Rapinyl (Abstral) for use in cancer pain.

FDA lifts clinical hold on Aerolef

YM BioSciences have announced that the FDA has lifted a clinical hold posed on its inhaled fentanyl compounf AeroLEF.

FDA Advisory committee recommends against expanded use of Fentora

An FDA Advisory Committee has recommended against the expanded use of Fentora for the management of breakthrough pain in opioid-tolerant patients with chronic pain conditions.

FDA Advisory Committee votes No on Fentora for Chronic Pain

An FDA advisory committee has voted against approving Fentora (fentonyl buccal tablet) for the management of breakthrough pain in opioid-tolerant patients with chronic pain conditions. Fentora is currently approved for the management of breakthrough pain in opioid-tolerant patients with cancer.