U.S. FDA Approves LYRICA® CR (pregabalin) Extended-Release Tablets CV
- Category: Small Molecules
- Published on Thursday, 12 October 2017 17:44
- Hits: 722
New formulation may offer convenience to patients
NEW YORK, NY, USA I October 12, 2017 I Pfizer Inc. (NYSE: PFE) announced today that the United States Food and Drug Administration (FDA) has approved LYRICA® CR (pregabalin) extended-release tablets CV as once-daily therapy for the management of neuropathic pain associated with diabetic peripheral neuropathy (pDPN) and the management of postherpetic neuralgia (PHN). LYRICA CR did not receive approval for the management of fibromyalgia.
“LYRICA CR was developed to offer patients an effective treatment option with the convenience of once-daily dosing,” said James M. Rusnak, MD, PhD, Chief Development Officer, Internal Medicine, Pfizer Global Product Development. “It provides an important option for patients and health care providers managing these often debilitating pain conditions.”
The efficacy and safety of LYRICA CR in PHN was established in a randomized placebo-controlled clinical trial conducted in a total of 801 patients with PHN who entered single-blind treatment with LYRICA CR. As both pDPN and PHN are peripheral neuropathic pain conditions, the PHN data was supportive of both the pDPN and PHN indications. The randomized trial included a six-week single-blind, dose optimization phase followed by a 13-week double-blind phase. In the PHN study, 73.6 percent of patients in the LYRICA CR group achieved at least 50 percent improvement in pain intensity compared with 54.6 percent in the placebo group.
The most common adverse reactions reported with LYRICA CR were dizziness, somnolence, headache, fatigue, peripheral edema, nausea, blurred vision, dry mouth and weight gain.
Please see the full prescribing information and Medication Guide for LYRICA CR (pregabalin) extended-release tablets here.
Important Safety Information
Prescription LYRICA CR is not for everyone. Patients should tell their doctor right away about any serious allergic reaction that causes swelling of the face, mouth, lips, gums, tongue, throat, or neck or any trouble breathing, rash, hives, blisters or skin redness. LYRICA CR may cause suicidal thoughts or actions in a very small number of people. Patients, family members or caregivers should call the doctor right away if they notice suicidal thoughts or actions, thoughts of self harm, or any unusual changes in mood or behavior. These changes may include new or worsening depression, anxiety, restlessness, trouble sleeping, panic attacks, anger, irritability, agitation, aggression, dangerous impulses or violence, or extreme increases in activity or talking. If patients have suicidal thoughts or actions, they should not stop LYRICA CR without first talking to their doctor. LYRICA CR may cause swelling of the hands, legs and feet. Some of the most common side effects of LYRICA CR are dizziness and sleepiness. Patients should not drive or work with machines until they know how LYRICA CR affects them. Other common side effects are tiredness, headache, nausea, blurry vision, weight gain, and dry mouth. Also, patients should tell their doctor right away about muscle pain along with feeling sick and feverish, or any changes in eyesight including blurry vision or any skin sores in patients with diabetes. There may be a higher chance of swelling, hives or gaining weight in patients also taking certain diabetes or high blood pressure medicines. Patients should not drink alcohol while taking LYRICA CR. Patients may have more dizziness and sleepiness if taking LYRICA CR with alcohol, narcotic pain medicines, or medicines for anxiety. Patients who have had a drug or alcohol problem may be more likely to misuse LYRICA CR. Patients should tell their doctor if planning to father a child, if pregnant, or planning to become pregnant. Breastfeeding is not recommended while taking LYRICA CR. Patients should talk with their doctor before they stop taking LYRICA CR or any other prescription medication.
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