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.
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