Insys NDA set to increase crowding in US fentanyl market
This article was originally published in Scrip
Insys Therapeutics, a biopharmaceutical company focused on developing products to address chemotherapy-induced nausea and vomiting, pain management and other CNS disorders, has submitted a new drug application with the US FDA for its investigational cancer pain product candidate, fentanyl sublingual spray.
If approved, Insys plans to build its own sales force to market the product.
Insys provided results last March of its pivotal Phase III efficacy trial of the sublingual spray to treat breakthrough cancer pain. The trial met the primary endpoint, the sum of pain intensity differences from baseline to 30 minutes (SPID-30), and fentanyl sublingual spray significantly improved mean SPID-30 scores compared to placebo (p<0.0001). additionally,="" the="" sublingual="" spray="" significantly="" improved="" mean="" pain="" response="" compared="" with="" placebo="" as="" early="" as="" five="" minutes="" (p="0.022).">
If its product progresses, Insys would join an increasing crowded market in the US for fentanyl products for breakthrough cancer pain. Breakthrough cancer pain is seen in approximately 75% of patients with cancer. Insys estimated that over a half-million people in the US with cancer suffer from breakthrough pain, but only about 25,000 are treated for it.
Meda Pharmaceuticals' Onsolis (fentanyl buccal soluble film) is one of the newest entries, after FDA approval in July 2009. The product, approved for adults, is delivered through an absorbable film that sticks to the inside of the cheek.
Earlier this year, the UK-based specialty pharma company ProStrakan, which is in the process of being acquired by Kyowa Kirin, received FDA approval for its sublingual fentanyl tablets, Abstral (licensed from Orexo), for the management of breakthrough cancer pain in adults; the product is to be launched this quarter (scripintelligence.com, 10 January 2011). It has been available in Europe since 2009. Archimedes Pharma has under review at the FDA PecFent (fentanyl pectin nasal spray), its own product for the condition; the firm opened up a US headquarters in Bedminister, New Jersey last August in anticipation of US approval. The product is available in Europe and was recently approved for reimbursement in Scotland (scripintelligence.com, 19 January 2011).
Cephalon has two older rival products approved in the US for breakthrough cancer pain: the fentanyl transmucosal coated-stick formulation, Actiq, and the fentanyl buccal lozenge, Fentora.
Last November Insys completed a merger with NeoPharm and changed the name of the combined entity to Insys Therapeutics. Insys' focus has been on applying new and proprietary formulations and delivery methods to existing pharmaceutical compounds to achieve enhanced efficacy, faster onset of action, reduced side effects, convenient delivery and increased patient compliance.