Archimedes submits NasalFent MAA

UK drug developer Archimedes Pharma has submitted a centralized Marketing Authorization Application to the European Medicines Evaluation  Agency (EMEA) for approval of its lead product candidate, NasalFent, a  fentanyl nasal spray for the rapid relief of breakthrough cancer pain.

The NasalFent development program involved over 100 investigational  sites in 13 countries across four continents. Data from this program  showed that NasalFent met both its primary and secondary endpoints, and  showed a statistically-significant difference in pain scores compared  to placebo within five minutes of dosing. Patients and physicians  rated NasalFent highly in terms of convenience, acceptability and speed  of onset of pain relief. In addition, the need for rescue medication  occurred in less than 6% of episodes.

Archimedes also signed two key distribution agreements for French  drug-delivery specialist Ethypharm's sustained release morphine sulphate  capsule, Zomorph, extending its UK marketing rights to the product and  securing first-time marketing rights in a number of new European  territories including Spain, France, Belgium and Luxembourg.