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.
Reinvigoration of the U.S. Market
Reinvigoration of the U.S. market is expected following approval of Fentora for noncancer pain and the launch of several new brands over the next few years. Datamonitor forecasts the U.S. market to grow from $600 million in 2008 to $1.1 billion in 2018.
While the clinical advantage of improved speed of onset of action demonstrated with spray formulations is promising, concerns regarding overdose potential may restrict the use of such formulations to a narrow patient population of breakthrough cancer pain patients. With no significant U.S. marketing partner currently signed-up to market a fentanyl spray formulation, potential partners appear to be waiting for an indication of the FDA view of this mode of delivery for strong opioids.
In contrast, should Cephalon prove successful in gaining a broader label for Fentora, new market entrants with dissolvable fentanyl formulations are likely to follow suit, expanding their revenue potential substantially.