NEW YORK, NY, USA I December 1, 2016 I Pfizer Inc. (NYSE:PFE) announced today positive top-line results of a study that evaluated the use of LYRICA® (pregabalin) Capsules CV and Oral Solution CV as adjunctive therapy for pediatric epilepsy patients four to 16 years of age with partial onset seizures. Results showed that adjunctive treatment with LYRICA 10 mg/kg/day resulted in a statistically significant reduction in seizure frequency versus placebo, the primary efficacy endpoint. Treatment with LYRICA 2.5 mg/kg/day resulted in a numerical reduction in seizure frequency, which was not statistically significant. LYRICA is not approved as adjunctive therapy for pediatric epilepsy patients with partial onset seizures.
“At Pfizer we believe it is important to continue to study our medicines in relevant populations,” said Rory O’Connor, MD, Chief Medical Officer, Internal Medicine, Pfizer Inc. “Epilepsy remains a common and debilitating condition worldwide, and these results make a substantial contribution to the body of evidence for LYRICA in the pediatric population.”
The LYRICA Pediatric Epilepsy Program is composed of a total of six studies in patients with epilepsy evaluating LYRICA as adjunctive therapy, three of which have been completed and three are actively enrolling.
About the Study
This Phase 3 study was a 12-week double-blind, placebo-controlled, randomized, parallel group, multi-center study including two fixed LYRICA doses. The study was conducted at 76 sites in 18 countries with 295 subjects four to 16 years of age. Subjects were randomized to placebo, LYRICA 2.5 mg/kg/day or LYRICA 10 mg/kg/day.
The safety profile observed in this study was consistent with that known for LYRICA in adults. No unexpected or new safety findings were reported in the pediatric patients with POS in this study. The most common adverse events with LYRICA 10 mg/kg/day in this study were somnolence, weight increase, increased appetite and pyrexia. The most common adverse events with LYRICA 2.5 mg/kg/day were somnolence, upper respiratory tract infection, nasopharyngitis and cough.
Complete study results are expected to be submitted for presentation at an upcoming scientific congress and for publication in a peer-reviewed medical journal.
Epilepsy is a chronic disorder characterized by recurrent, unprovoked seizures and occurs in both adults and children. Sixty-five million people worldwide have epilepsy. One in 26 individuals in the U.S. will develop epilepsy at some point in their lifetime. About three million people in the U.S. are living with epilepsy, of which approximately 10 percent or 300,000 are pediatric patients. Partial onset seizures are the most common seizure type.
LYRICA® is currently approved for various indications in more than 130 countries and regions globally.
In the U.S., LYRICA is indicated to treat fibromyalgia, diabetic nerve pain, spinal cord injury nerve pain and pain after shingles in adults. LYRICA is also indicated to treat partial onset seizures in adults with epilepsy who take one or more drugs for seizures.
Important Safety Information
LYRICA is not for everyone. LYRICA may cause serious, even life threatening, allergic reactions. Stop taking LYRICA and call your doctor right away if you have any signs of a serious allergic reaction. Some signs are swelling of your face, mouth, lips, gums, tongue, throat or neck or if you have any trouble breathing, or have a rash, hives or blisters.
Drugs used to treat seizures increase the risk of suicidal thoughts or behavior. LYRICA may cause suicidal thoughts or actions in a very small number of people, about 1 in 500. 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 you have suicidal thoughts or actions, do not stop LYRICA without first talking to your doctor.
LYRICA may cause swelling of your hands, legs and feet, which can be serious for people with heart problems. LYRICA may cause dizziness and sleepiness. You should not drive or work with machines until you know how LYRICA affects you. Also, tell your doctor right away about muscle pain or problems along with feeling sick and feverish, or any changes in your eyesight including blurry vision or if you have any kidney problems or get dialysis.
Some of the most common side effects of LYRICA are dizziness, blurry vision, weight gain, sleepiness, trouble concentrating, swelling of your hands and feet, dry mouth, and feeling “high.” If you have diabetes, tell your doctor about any skin sores.
You may have a higher chance for swelling and hives if you are also taking angiotensin-converting enzyme (ACE) inhibitors so tell your doctor if you are taking these medications. You may have a higher chance of swelling of your hands or feet or gaining weight if you are also taking certain diabetes medicines. Do not drink alcohol while on LYRICA. You may have a higher chance for dizziness and sleepiness if you take LYRICA with alcohol, narcotic pain medicines, or medicines for anxiety.
Before you start LYRICA, tell your doctor if you are planning to father a child, or if you are pregnant, or plan to become pregnant. Breastfeeding is not recommended while taking LYRICA. If you have had a drug or alcohol problem, you may be more likely to misuse LYRICA.
In studies, a specific type of blood vessel tumor was seen in mice, but not in rats. The meaning of these findings in humans is not known.
Do not stop taking LYRICA without talking to your doctor. If you stop suddenly you may have headaches, nausea, diarrhea, trouble sleeping, increased sweating, or you may feel anxious. If you have epilepsy, you may have seizures more often.