title: Post-marketing experience with an opioid nasal spray for migraine: lessons for the future.
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.
authors.affiliation: Harvard Medical School, Boston, MA, USA. eloder@partners.org
authors.forename: E
authors.initials: E
authors.lastname: Loder
mesh_terms: D000281:Administration, Intranasal; D000701:Analgesics, Opioid / Q000009:adverse effects / Q000627:therapeutic use; D002077:Butorphanol / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use*; D017277:Drug Approval / Q000379:methods* / Q000458:organization & administration*; D005544:Forecasting; D006801:Humans; D008881:Migraine Disorders / Q000188:drug therapy*; D011358:Product Surveillance, Postmarketing / Q000379:methods* / Q000639:trends; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D000701:Analgesics, Opioid; D002077:Butorphanol