Morphine Approved for Chronic Pain

FDA approves morphine sulfate solution for opioid-tolerant patients.
The AP (1/26) reported that the FDA "says it has confirmed the safety of a widely-used formulation of morphine that was previously unapproved." Regulators "approved Roxane Laboratories' Morphine Sulfate oral solution for patients with moderate to severe chronic pain." The agency "issued warning letters to Roxane and eight other drugmakers" last March "ordering them to stop distributing their morphine drugs."
MedPage Today (1/26, Petrochko) reported that Roxane's drug "is indicated for opioid-tolerant patients with moderate-to-severe acute and chronic pain, as well as end-of-life care." Opioid-tolerant patients are those who use "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." To gain approval, Roxane Laboratories "needed to establish a safety profile...to address the risks of morphine misuse, abuse, and overdose."