PecFent is currently under review by FDA.
Archimedes Pharma’s lead fentanyl nasal spray product, PecFent, was granted approval by the European regulatory authorities for the treatment of breakthrough cancer pain in adults already receiving maintenance opioid therapy. An NDA submitted to FDA during August 2009 is currently under review.
PecFent is delivered using Archimedes’ PecSys™ nasal drug delivery system. The firm says Phase III trials confirmed the treatment can provide initial relief from cancer pain within five minutes of administration and clinically meaningful benefits within 10 minutes. “This is a transformative milestone for Archimedes Pharma as we have established commercial operations in Europe and look forward to launching PecFent in major European markets in the coming months,” remarks president and CEO Jeffrey H. Buchalter.
The Phase III program for PecFent included three pivotal studies, including an active comparator study and a long-term safety and acceptability trial. Over 650 patients and 100 investigational sites in 13 countries were involved in late-stage development of the product. Archimedes says it is currently in the process of establishing a U.S. commercial operation in anticipation of FDA approval.
Archimedes is building a pipeline of product candidates based on its proprietary technologies. ChiSys® is a bioadhesive technology the firm claims increases the time that drugs reside on mucosal membranes and increases bioavailability. It hopes the technology could replace the need for injection-based delivery of some drugs. PecSys is a pectin-based gelling technology that Archimedes says can optimize the profile of drugs that are well-absorbed by the nasal mucosa, to allow rapid absorption with reduced dose spiking, or control absorption so that the drug effects last longer. Targit® is an oral delivery technology designed to deliver drugs directly to the lower gastrointestinal tract.
The firm’s in-house clinical pipeline includes intranasal morphine and buprenorphine products for pain relief, along with an intranasal apomorphine in development for Parkinson’s disease, and an intranasal vaccine against flu.
Archimedes is also exploiting its drug delivery technologies through product-development partnerships with firms including Javelin Pharmaceuticals, Pharmalink, Almac, and Ligocyte Pharmaceuticals. It has in addition licensed in a number of marketed products. The firm says it aims to both progress its in-house pipeline and grow its commercial presence through the acquisition of marketed brands and through partnering or licensing of European or U.S. rights to new specialty pharmaceuticals.