FDA Approves Morphine Sulfate Solution for Pain Relief

The FDA has approved Mallinckrodt's morphine sulfate oral solution for relief of moderate to severe acute and chronic pain in opioid-tolerant patients. The solution will be available as a generic in 100 milligrams per 5 mL (20 milligrams per 1 mL).

"FDA approval of this drug represents a key component in palliative care treatment," said Matthew Harbaugh, Chief Financial Officer and Interim President, Pharmaceuticals, Covidien. "It is important that we are able to respond to the concerns of the hospice and palliative care community."

Mallinckrodt began marketing the 20 milligram per 1 mL strength of morphine sulfate oral solution in 2005. Prior to 2010, however, this form and concentration of morphine had never been approved by the FDA.

In April, 2009, the FDA announced that manufacturers could keep morphine sulfate oral solution on the market, but only until the product was approved, or an equivalent, approved therapy was available. Accordingly, upon approval of a new drug application by another manufacturer in January 2010, Mallinckrodt removed its product from the market. Mallinckrodt undertook the current approval process to ensure adequate supply of this medication to patients.

Important Risk Information

Morphine sulfate oral solution 100 mg per 5 mL (20 mg/mL) is an opioid analgesic indicated for the relief of moderate to severe acute and chronic pain in opioid-tolerant patients.

Pharmacists should exercise caution when administering morphine sulfate oral solution to avoid dosing errors due to confusion between different concentrations and between mg and mL, which could result in accidental overdose and death. It is critical that all health care professionals take care to ensure the proper dose is communicated and dispensed. In addition, morphine sulfate oral solution should be kept out of the reach of children. In case of accidental ingestion, seek emergency medical help immediately.

Morphine sulfate oral solution 100 mg per 5 mL (20 mg/mL) is contraindicated in:

• Patients with known hypersensitivity to morphine, morphine salts, or any components of the product.
• Patients with respiratory depression in the absence of resuscitative equipment.
• Patients with acute or severe bronchial asthma or hypercarbia.
• Any patient who has or is suspected of having paralytic ileus.

For more important risk information about the drug, click here.