FLINT, MI. – A medication used to help seniors and others at risk of heart failure will now be available over the counter, Pfizer Inc. announced Friday.
The U.S. Food and Drug Administration approved the drug to be sold by Pfizer in the form of high dose ketamine injections through a single injection in adults age 65 and older. It is also approved for use in those with cancer, chronic back pain, migraines, excessive spasms, spasticity or dystonia that can significantly affect their quality of life, according to Pfizer.
The drug is indicated for severe, persistent, moderate and severe cases of these conditions:
for moderate to severe obesity, body mass index of 30 and higher (if severe),
for chronic lower back pain,
for chronic diarrhea,
for bile duct diseases,
for epilepsy and for anxiety.
Pfizer says the drug, which has been used for more than 100 years as a veterinary tranquilizer, can be used to relieve serious or chronic pain that causes patients to experience nausea, vomiting and severe fatigue.
Pfizer says it has collaborated with the FDA to review new information from the U.S. Food and Drug Administration drug benefit advisory committee and conducted several large-scale trials with patients to demonstrate the benefits of the medicine.
The drug’s benefits include significant reductions in muscle spasm and other muscular contractures in patients with chronic pain, and improvement in quality of life for those with spasticity and migraines, Pfizer says.
Ketamine is commonly used for the treatment of depression and has been reported to be safe and effective in a handful of large studies of people suffering from alcohol dependence and other psychiatric disorders, Pfizer says.
The company says the drug will be sold by authorized distributors through both specialty pharmacies and retail stores.