Pfizer recently announced that its epilepsy drug Lyrica (pregabalin), failed to meet primary endpoint in Phase III study, assessing it as adjunctive therapy in epilepsy patients (aged 5 to 65 years) with primary generalized tonic-clonic (“PGTC”) seizures reports Yahoo Finance.
Data showed that treatment with Lyrica wasn’t able to achieve a statistically significant reduction in seizure frequency versus placebo in the PGTC seizure patient population. Lyrica is currently approved for fibromyalgia, diabetic nerve pain, spinal cord injury nerve pain and pain after shingles.
The FDA required that the sponsor conduct this study as a post-marketing requirement. Although Lyrica is not approved as adjunctive therapy for PGTC seizures in any patient population.
Two doses of Lyrica were evaluated in the study—5 mg/kg/day and 10 mg/kg/day—over a 12 week period. The safety profile was similar to early studies.
A medication used to treat epilepsy, neuropathic pain, fibromyalgia, restless leg syndrome, and generalized anxiety disorder. Its use in epilepsy is as an add-on therapy for partial seizures. When used before surgery, it improves pain but results in greater sedation and visual disturbances. It is taken by mouth.
Common side effects include headache, dizziness, sleepiness, confusion, trouble with memory, poor coordination, dry mouth, problem with vision, and weight gain. Serious side effects may include angioedema, drug misuse, and an increased suicide risk. When pregabalin is taken at high doses over a long period of time, addiction may occur, but if taken at usual doses the risk is low. Use during pregnancy or breastfeeding is of unclear safety. Pregabalin is a gabapentinoid and acts by inhibiting certain calcium channels.
Pregabalin was approved for medical use in the United States in 2004. It was developed as a successor to gabapentin. It is available as a generic medication in a number of countries but not the United States as of 2018. In the US the wholesale costs is about US$450 per month as of 2019. While in the United Kingdom a similar dose costs the NHS about £6. In 2016, it was the 83rd most prescribed medication in the United States with more than 9 million prescriptions. In the US, Pregabalin is a Schedule V controlled substance under the Controlled Substances Act of 1970.
In May 2018, Lyrica successfully completed a Phase III study on pediatric patients with epilepsy. Top-line results from the study revealed that adjunctive treatment with Lyrica 14 mg/kg/day resulted in a statistically significant reduction in frequency versus placebo, which was the primary efficacy endpoint. Lower doses (7 mg) however did not result in statistically significant reduction in seizure frequency versus placebo.
The drug was granted pediatric exclusivity in November 2018 based on the data from the 2018 study. It was extended again till June 30, 2019. Lyrica is set to face generic competition in the U.S. markets post June 30.