FRIDAY, July 1, 2011 (HealthDay News) -- Lazanda (fentanyl) nasal spray has been approved by the U.S. Food and Drug Administration to treat breakthrough pain in adults with cancer who are already receiving opioid therapy, drug maker Archimedes Pharma said.
Breakthrough pain occurs as an intense, unpredictable burst among people who are already receiving therapy for chronic pain. Lazanda is the first nasal spray containing the commonly prescribed opioid painkiller fentanyl, the company said in a news release. Lazanda is available in five European countries under the brand name PecFent.
Lazanda will be prescribed under a Risk Evaluation and Mitigation Strategy (REMS) program to minimize instances of abuse and addiction, the drug maker said. The program requires pharmacies, distributors and doctors who prescribe the medication to enroll.
The drug's safety and effectiveness were established in clinical studies involving more than 500 people, Archimedes said. The most common adverse reactions were vomiting, nausea, fever and constipation.
Archimedes, headquartered in England, has a U.S. subsidiary based in Bedminister, N.J.
The U.S. National Institute on Drug Abuse has more about fentanyl.