Attracted by the significant revenue generation of Actiq at peak (global sales of $650 million in 2006), a large patient base, and comparatively low market entry barriers, short- and rapid-acting opioids have become a target for drug delivery and specialty companies keen to leverage their technology platforms. With a well-established efficacy and safety profile, opioids represent an ideal drug class for drug delivery companies as clinical trial risk is reduced. Although the degree of novelty varies significantly, all of the late-stage pipeline drugs are reformulations of established molecules.
In addition to oral dissolvable formulations such as BioDelivery Science’s and Meda’s Onsolis and ProStrakan’s Abstral, significant activity can be observed in the late-stage pipeline for spray formulations of fentanyl. While oral dissolvable formulations offer competition to Cephalon’s franchise, the spray formulations offer a clear improvement on speed of action—a key characteristic for any breakthrough pain drug.
For example, Archimedes’ intranasal formulation of fentanyl, Nasalfent, has shown significant analgesia as early as five minutes following administration. Alternative spray formulations in development include Akela Pharma’s inhaler, Fentanyl TAIFUN, and Nycomed’s intranasal formulation, Instanyl.