FDA approved thanks to a concerted effort by many in the hospice and palliative care community. To give a little history, in March the FDA issued warning letters to nine companies telling them to stop manufacturing (within 60 days) 14 unapproved 'narcotics' that are used to treat pain, including morphine oral solution. As you can imagine this created quite a little stir in the palliative care community and in our blogosphere.
AAHPM, NHPCO, and the HPNA leaders came together, as well as online social networks that included blogs like Pallimed and networks like facebook. They expressed strong concern that taking liquid morphine off the market would result in hardship for terminally ill patients and their caregivers. Within 9 days of the announcement the FDA reversed their decision. At that point the FDA agreed to allow companies making and distributing the unapproved drugs to continue, until 180 days after any company receives approval to manufacture a new morphine replacement drug of the same dosage.
Yesterday a company finally did get approval. The FDA approved Roxane Laboratories' Morphine Sulfate oral solution for relief of moderate to severe, acute and chronic pain in opioid-tolerant patients. The approved concentrations are available in 100 milligrams per 5 mL or 20 milligrams per 1 mL. This news does give me some pause as this is now the only FDA approved morphine sulfate oral solution available at this concentration. I worry that in 180 days we may be facing manufacturing shortages of liquid morphine. Hopefully another press release will come soon addressing these concerns.
Thanks to everyone for putting up a united front on this matter. It shows that a group of people can come together and make a difference!