Pfizer's Lyrica CR (pregabalin) extended-release tablets CV gained US Food and Drug Administration (FDA) approval for use treating neuropathic pain experienced by patients with diabetic peripheral neuropathy, and for managing postherpetic neuralgia.
The drug's safety and efficacy were established in a randomized placebo-controlled clinical trial of 801 patients with diabetic peripheral neuropathy. The study revealed almost three-quarters of patients who took Lyrica CR achieved at least 50 percent improvement in pain intensity, compared with 54.6 percent in the placebo group.
Almost one in ten people in the United States have diabetes, more than 30 million in total, according to the latest National Diabetes Statistics Report 2017 from the Centers for Disease Control and Prevention (CDC). Diabetic peripheral neuropathy has no known cure, so treatment focuses on managing the symptoms, relieving pain, and slowing the progression of the disease. Other medications used to relieve pain include Neurontin (gabapentin) and Tofranil (imipramine).
Lyrica is already utilized as a treatment for a number of other conditions, including spinal cord injury nerve pain, pain after shingles and as an add-on treatment for partial onset seizures in adults. It is also used to treat fibromyalgia, but the latest extended release formulation failed to gain FDA approval as a treatment for this condition.
James M Rusnak, MD, PhD, chief development officer, internal medicine, Pfizer Global Product Development, revealed the extended release formulation was developed to offer an effective treatment option with the convenience of once-daily dosing. "It provides an important option for patients and health care providers managing these often debilitating pain conditions," he stated.
The drug is contraindicated for anyone with hypersensitivity to pregabalin or any of its components. The most common adverse reactions to Lyrica are dizziness, somnolence, dry mouth, edema, blurred vision, weight gain, and abnormal thinking (particularly difficulty with concentration or attention).
For more information on Lyrica, visit https://www.lyrica.com