Lyrica (pregabalin; Pfizer/Eisai) is a gamma-aminobutyric acid alpha-2-delta subunit agonist, developed and launched by Pfizer (formerly Warner-Lambert) as the successor to Neurontin (gabapentin), which lost patent protection in the EU in 2003 and the US in 2004. Lyrica is available as an oral capsule and an oral solution.
Lyrica was first approved in the EU in July 2004 and in the US in September 2005 for the adjunctive therapy for partial seizures in adult epilepsy patients. The drug subsequently launched for this indication in the UK and Germany in September and October 2004, respectively. Since its initial launch, Pfizer has rapidly expanded Lyrica’s indication coverage across the US, Japan, and five major EU markets (France, Germany, Italy, Spain, and the UK) to include a range of pain, neurological, and psychiatric conditions. However, there has been slow progress in other epilepsy indications.
Compared to other key brands, Lyrica (pregabalin; Pfizer/Eisai) has relatively narrow epilepsy coverage, and its additional indications are in non-epilepsy conditions. As such, Lyrica has a low patient potential in the epilepsy market and this is not expected to change in the near future. Despite positive efficacy results from the clinical investigation of Lyrica for the monotherapy treatment of partial-onset seizures, Pfizer does not look like it will be pursuing approval in this indication. In addition, attempts to protect the Lyrica franchise by developing a once-daily controlled-release (CR) formulation of the drug for the treatment of epilepsy were not successful. Datamonitor Healthcare believes that Pfizer will continue to focus its attention on markets outside of epilepsy, including neuropathic pain conditions, for which Lyrica has performed very well.
TABLE OF CONTENTS
4 PRODUCT PROFILES
4 Lyrica : Epilepsy
LIST OF FIGURES
12 Figure 1: Lyrica for epilepsy – SWOT analysis
14 Figure 2: Datamonitor Healthcare’s drug assessment summary for Lyrica in epilepsy
14 Figure 3: Datamonitor Healthcare’s drug assessment summary for Lyrica in epilepsy
LIST OF TABLES
5 Table 1: Lyrica drug profile
7 Table 2: Lyrica pivotal trial data in epilepsy
9 Table 3: Safety profile for Lyrica in epilepsy
11 Table 4: Lyrica ongoing late-phase trials for pediatric and adult epilepsy indications
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