Post-marketing experience with an opioid nasal spray for migraine: lessons for the future

Cephalalgia. 2006 Feb;26(2):89-97. doi: 10.1111/j.1468-2982.2005.00951.x.

Abstract

In 1992 a nasal spray formulation of butorphanol, an opioid medication intended for pain relief, was marketed in the USA on an unscheduled basis. Only a few years later, amid widespread reports of abuse and dependence, primarily in migraine patients, its manufacturer voluntarily requested the Food and Drug Administration to reschedule the drug as a Schedule IV narcotic. The events surrounding this episode are reviewed, and four problem areas that might have contributed are identified: (i) inadequate review of previous experience with other formulations of butorphanol; (ii) failure to consider the impact of disease state and drug formulation on the risk of adverse events; (iii) the limited scope of clinical trials prior to approval; and (iv) aggressive marketing efforts. The implications of these lessons for future drug development and post-marketing surveillance in the migraine field are considered.

Publication types

  • Review

MeSH terms

  • Administration, Intranasal
  • Analgesics, Opioid / adverse effects
  • Analgesics, Opioid / therapeutic use
  • Butorphanol / administration & dosage
  • Butorphanol / adverse effects*
  • Butorphanol / therapeutic use*
  • Drug Approval / methods*
  • Drug Approval / organization & administration*
  • Forecasting
  • Humans
  • Migraine Disorders / drug therapy*
  • Product Surveillance, Postmarketing / methods*
  • Product Surveillance, Postmarketing / trends
  • United States
  • United States Food and Drug Administration

Substances

  • Analgesics, Opioid
  • Butorphanol