On April 2, 2014, the FDA issued a draft guidance for fentanyl citrate nasal spray. The guidance offers an in vitro option, saying, “If the test product is qualitatively (Q1) and quantitatively (Q2) the same as the reference product, then bioequivalence may be documented by an in vitro approach in lieu of an in vivo approach.”
If bioequivalence cannot be demonstrated using the in vitro approach, a single PK study is recommended.
The FDA approved Lazanda fentanyl citrate nasal spray for the treatment of breakthrough cancer pain in July 2011. Archimedes developed the product using its proprietary pectin technology, and markets the product as PecFent in Europe. Depomed acquired the US and Canadian rights to Lazanda in July 2013.
View the draft guidance.
