By Amanda Toth , CNN Written by
Soon, residents of the United States could face quite a few more headaches, if The Food and Drug Administration has its way.
On Monday, the FDA announced plans to authorize Pfizer’s Lyrica for long-term use in the US. Previously, the drug had only been marketed for the treatment of diabetic peripheral neuropathic pain and fibromyalgia, and the anesthetic fluocinolone acetonide for the prevention of migraine headaches.
According to a FDA press release, the agency is currently awaiting additional clinical data from Pfizer to further evaluate the efficacy and safety of long-term administration of Lyrica.
The company is currently seeking FDA approval for the drug for patients with pain syndromes other than fibromyalgia, headache, diabetic peripheral neuropathic pain and nausea (due to chemotherapy).
“Pfizer is dedicated to innovating medicines that deliver real, positive benefits to patients, while respecting the medicine they are being developed to treat,” said Mikael Dolsten, president of Pfizer’s Worldwide Pharmaceuticals business.
“Recognizing the unmet need for a non-opioid therapy for a broad range of pain syndromes, we are pleased that FDA is taking the next steps toward evaluating the potential benefits of Lyrica for long-term use.”
Long-acting, nerve-blocking medications for chronic pain are a little known part of the treatment system, since their availability hasn’t been widely available, and in many cases, patients haven’t needed to prescribe the products themselves. But a 2012 study found that there are less than 10 long-acting, painkillers approved for use in the US and Australia, and only two approved for approval in Japan.
Pfizer is currently seeking approval for long-acting treatments for pain conditions of the neck, feet, abdomen, spines, the trunk, spine, chest, brain, and joints throughout the body.
Lyrica may also be approved to treat shortness of breath and other inflammation and dysfunction in the body associated with medical conditions, including Parkinson’s disease and bile duct disorders.
It was approved by the FDA for the treatment of chronic pain syndromes in 2001, and Lyrica is now available in 145 countries around the world.