FDA has approved Archimedes Pharma’s fentanyl nasal spray Lazanda® (fentanyl) for the management of breakthrough cancer pain in adult patients who are tolerant to opioid therapy. The drug formulation is already marketed as PecFent® in five countries in Europe.
Clearance of Lazanda represents FDA’s first approval of a fentanyl spray and is also Archimedes’ first U.S. approval, the firm states. The drug will be launched during the second half of 2011 with a risk evaluation and mitigation strategy program.
Lazanda has been formulated using Archimedes’ pectin-based PecSys delivery system, which administeres a low-volume, low-viscosity aqueous solution to the mucus membrane as a fine mist. The mist forms a gel on contact with the mucosa, and the active fentanyl ingredient is absorbed across the mucus membrane into the blood stream.
Archimedes is a specialty pharmaceutical company focused on oncology, pain, neurology, and critical care sectors. The firm is exploiting two nasal drug delivery platforms, PecSys and ChiSys®, and a gastrointestinal drug delivery technology called Targit®.
ChiSys is a bioadhesive technology developed to increase the time that drugs reside on mucosal membranes and increases bioavailability, which the firm maintains could replace the need to use injections to deliver some drugs. Targit is designed to facilitate the release of drugs specifically within the lower gastrointestinal tract by protecting against acid- and enzyme-related degradation in the upper gastrointestinal tract.
The approach effectively coats drugs drug-loaded capsules with a combination of enteric polymers, with the choice and thickness of the coating determining the site of release within the gastric tract. Archimedes says Targit can in addition be combined with several formulation approaches such as absorption enhancement or controlled release to provide sustained-release characteristics.
In addition to developing its own pipeline of products, the firm’s Archimedes Development subsidiary offers pharmaceutical services on a contract basis, including research and formulation development, clinical trial manufacturing, analytical/QC and bioanalytical services, the co-ordination and monitoring of clinical trials, and manufacturing transfer to commercial scale.