We are well-equipped to discover and develop innovative drugs.
Currently, BIAL has projects for new drugs underway, including Phase I, II and III clinical trials.
The European Commission, on April 21st 2009, and more recently, on November 8th 2013, the Food and Drug Administration (FDA), United States, approved a marketing authorization valid throughout the European Union and United States, respectively, for eslicarbazepine acetate as adjunctive therapy in adults with partial-onset seizures, with or without secondary generalization. On August 27th 2015, FDA approved BIAL’s antiepileptic as monotherapy in the U.S., and it can now be used there in people who initiate treatment for the first time or convert from other antiepileptic drugs.
The clinical development program of eslicarbazepine acetate is ongoing. New studies are being carried out to evaluate new therapeutic indications of eslicarbazepine acetate, including its use as monotherapy in Europe and in pediatrics.
- Eslicarbazepine acetate in “BRAIN”
- BIAL’s antiepileptic is now in the U.S. pharmacies
- BIAL’s antiepileptic approved in the U.S.
- FDA approves Aptiom as monotherapy
Opicapone is a novel third generation catechol-O-methyltransferase (COMT) inhibitor, providing potent and sustained COMT inhibition. This action enhances the beneficial effects of levodopa in Parkinson’s disease patients with motor fluctuations. Opicapone is supported by a large and comprehensive clinical development programme. Data from the pivotal studies BIPARK I and II has been presented at various international scientific congresses. Opicapone has just received positive opinion from the Committee for Medicinal Products for Human Use (CHMP), recommending to grant a Marketing Authorization in all member states of the European Union.
Parkinson's disease is a degenerative disorder of the central nervous system characterized by bradykinesia (slowness of movement), tremor, muscle rigidity and postural instability. The clinical manifestations usually start after the age of 50 years and the incidence increases with age. The prevalence is estimated at 300 per 100,000 inhabitants, increasing to 1/100 over the age of 55–60 years.
1. Ferreira JJ, Lees A, Rocha JF, Poewe W, Rascol O, Soares-da-Silva P; Bi-Park 1 investigators. Opicapone as an adjunct to levodopa in patients with Parkinson's disease and end-of-dose motor fluctuations: a randomised, double-blind, controlled trial. Lancet Neurol. 2015 Dec 22. doi: 10.1016/S1474-4422(15)00336-1. [Epub ahead of print]
2. Rocha JF, Falcão A, Santos A, Pinto R, Lopes N, Nunes T, Wright LC, Vaz-da-Silva M, Soares-da-Silva P. Effect of opicapone and entacapone upon levodopa pharmacokinetics during three daily levodopa administrations. Eur J Clin Pharmacol. 2014 Sep;70(9):1059-71.
- Opicapone significantly improves OFF-time in fluctuating Parkinson’s Disease patients as add-on to levodopa
- BIAL licenses a new medicine for Parkinson
BIAL is member of the European Parkinson's Disease Association.