The FDA has approved the first high-concentration, oral morphine sulfate solution as part of its unapproved drugs initiative.
The drug is indicated for opioid-tolerant patients with moderate-to-severe acute and chronic pain, as well as end-of-life care.
Opioid tolerance was defined as a patient using 60 mg of an opioid per day, Sharon Hertz, MD, deputy director of the Division of Anesthesia, Analgesics, and Rheumatoid Products at the Center for Drug Evaluation and Research, said in a conference call.
The new solution is available in 100 mg per 5 mL and 20 mg per 1 mL concentrations.
Although morphine use in pain management has been a common practice, this form and concentration of the drug was not previously FDA approved.
Approval for the new drug was based on efficacy and safety data already available, which applicants can use when seeking approval for unapproved formulations of drugs with a known safety profile, Hertz said.
The FDA initiated the unapproved drugs initiative in March, 2009, when it sent warning letters to nine companies requesting they pull a number of morphine sulfate, oxycodone, and hydromorphone products from the market. (See FDA Acts Against Unapproved Narcotic Drugs)
Seven of the warned companies produced unapproved concentrated morphine sulfate, but the FDA granted a reprieve from the initiative when it could not find a suitable approved replacement for the drug without disrupting patient care. (See FDA Gives Temporary Reprieve to Unapproved Morphine Elixir)
The agency worked with manufacturer Roxane Laboratories to ensure that a sufficient supply of the drug was available and to develop a prescription and use guide for the medication.
As part of the approval, the manufacturer needed to establish a safety profile prior to approval to address the risks of morphine misuse, abuse, and overdose.
By Cole Petrochko
January 26, 2010
Med Page Today
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