(MENAFN- ProactiveInvestors)
's () Lyrica pain drug has failed to meet U.S. Food and Drug Administration (FDA) requirements in a post-marketing study testing the treatment of fibromyalgia in adolescents.
The main goal of the FDA-mandated test the results of which were announced after market close on March 12 was to evaluate the safety and effectiveness of Lyrica in treating teenagers (12-17 years) suffering from fibromyalgia (FM).
The study concluded that no statistically significant difference between Lyrica and the placebo arm was observed in the mean pain score.
conducted the study which enrolled 107 adolescent patients in a randomized double-blind placebo-controlled test that lasted 15 weeks throughout the U.S. Europe and Asia. This study is the first large pharmacological treatment study to be completed in this study population.
"Lyrica has more than 10 years of real world experience supporting the needs of patients and remains an important treatment choice for healthcare professionals" said senior VP and head of Global Medicines Development for the Global Innovative Pharmaceutical business Steve Romano.
"These results do not change the established benefit of Lyrica for its approved indications including fibromyalgia in adults."
Fibromyalgia is a chronic rheumatic disease characterized by widespread musculoskeletal pain and fatigue. It affects millions of people worldwide. Patients with fibromyalgia often also suffer from depression as a result of the impact the disease has on daily life.
Lyrica (pregabalin) has been approved by the FDA in the US and 139 other countries to treat the disorder and the drug helps to alleviate nerve pain in patients. In the US Lyrica has also been approved to reduce neuropathic pain due to diabetic disorders spinal cord injuries and neuralgia.
News of the test failure will add disappointment to what has already proven to be a difficult year for the New York-based drug maker the biggest in the US marked by patent expirations for key drugs and a stronger US dollar.
It is therefore crucial for to find new avenues to generate revenue.
Over the past few years Lyrica has been one of ’s biggest revenue generators. In 2013 alone Lyrica sales topped US$4.6 billion prompting to identify additional applications for the drug.
has also been expanding its vaccine product line-up through its own research and by looking out for related assets to acquire.
The company's shares were trading at US$33.83 per share down 0.5 percent on Friday afternoon.
Legal Disclaimer:
MENAFN provides the information “as is” without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the provider above.