The Food and Drug Administration will soon decide whether or not to approve Pfizer’s ProtagenaXR to treat depression, migraines, and migraine headaches, according to multiple reports.
The FDA has approved ProtagenaXR under certain conditions: It will need to be administered by either a designated healthcare professional or at a healthcare facility. According to the FDA’s website, the medication should be administered during an in-office procedure or at a daycare or nursing home. Afterward, ProtagenaXR must be stored at 0 degrees Fahrenheit or below.
The American Academy of Neurology says that the medication is likely to help primary episodic migraine patients. It was previously approved for use in adults after years of trial and error.
While the FDA’s decision is yet to be made, some experts and patients alike have been unsure about the meaning of the latest development. Some think that using medication approved for one purpose could be problematic — not to mention the long-term effects of taking specific types of medication. Others are hopeful about the possible benefits of the drug, though that optimism is clouded by fears about what happens if the FDA eventually decides against the medication.
The American Psychiatric Association has cautioned against talking about “medications for multiple disorders in an otherwise healthy individual,” because they worry that clinicians may underestimate the risk of pairing chemicals that affect the brain with different mental health issues.
In general, while prescribing a medication like ProtagenaXR “is not a black and white situation,” according to ADHD experts Jeff Guyer and Samina Rashid of the University of Minnesota, it can sometimes be helpful to apply the same rules when determining whether or not to prescribe a drug to a mixed group of conditions. “We don’t recommend that (patients) say, ‘Oh, if I get epilepsy, then I can take this drug.’”
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