FDA Okays Fentanyl Nasal Spray for Ca Pain - in Public Health & Policy, FDA General from MedPage Today
Medical News: FDA Okays Nasal Spray for Ca Pain - in Public Health & Policy, FDA General from MedPage Today
By Cole Petrochko, Associate Staff Writer, MedPage TodayPublished:
July 02, 2011 WASHINGTO -- The FDA has approved a nasal spray formulation of the drug fentanyl (Lazanda) to manage breakthrough pain in cancer patients ages 18 and older who are already using opioid therapy. The drug comes in 100 mcg- and 400 mcg-spray doses.
Drug efficacy was established in a double-blind study that found fentanyl nasal spray outperformed placebo at the primary endpoint of sum of pain intensity difference at 30 minutes.
The nasal spray formulation is not equivalent to other fentanyl products for breakthrough pain on a microgram-per-microgram basis. Healthcare professionals prescribing Lazanda should not convert from other fentanyl products. A dosage conversion guide is not available at this time.