Eslicarbazepine acetate
Encyclopedia
Eslicarbazepine acetate (BIA 2-093) is an antiepileptic drug. It is a prodrug
which is activated to eslicarbazepine (S-licarbazepine
), an active metabolite of oxcarbazepine
.
It is being developed by Bial
and will be marketed as Zebinix or Exalief by Eisai Co.
in Europe and as Stedesa by Sepracor
in America.
The European Medicines Agency
(EMA) has recommended granting marketing authorization in 2009 for adjunctive therapy
for partial-onset seizures, with or without secondary generalisation, in adults with epilepsy
.
The U.S. Food and Drug Administration (FDA) announced on 2 June 2009 that the drug has been accepted for filing.
There may, however, be pharmacokinetic differences. Eslicarbazepine acetate may not produce as high peak levels of (S)-(+)-licarbazepine immediately after dosing as does oxcarbazepine which could theoretically improve tolerability.
Like oxcarbazepine, eslicarbazepine may be used to treat bipolar disorder
and trigeminal neuralgia
.
to protect this drug is . The priority of this European patent is the Portuguese patent application .
Prodrug
A prodrug is a pharmacological substance administered in an inactive form. Once administered, the prodrug is metabolised in vivo into an active metabolite, a process termed bioactivation. The rationale behind the use of a prodrug is generally for absorption, distribution, metabolism, and...
which is activated to eslicarbazepine (S-licarbazepine
Licarbazepine
Licarbazepine is an active metabolite of oxcarbazepine....
), an active metabolite of oxcarbazepine
Oxcarbazepine
Oxcarbazepine is a anticholinergic anticonvulsant and mood stabilizing drug, used primarily in the treatment of epilepsy. It is also used to treat anxiety and mood disorders, and benign motor tics...
.
It is being developed by Bial
Bial
Bial is a pharmaceutical company headquartered in S. Mamede do Coronado, in Trofa, Porto district, Portugal. It was founded in 1924, being among the largest companies of its kind in Portugal....
and will be marketed as Zebinix or Exalief by Eisai Co.
Eisai Co.
is a Japanese pharmaceutical company, ranking among the top 25 in the world by revenue and achieving $8 billion USD in sales for the fiscal 2008 year. Headquartered in Tokyo, Japan, it has some 10,000 employees, among them about 1,500 in research. Eisai is a member of the Topix 100 and Nikkei 225...
in Europe and as Stedesa by Sepracor
Sepracor
Sepracor, Inc. is a pharmaceutical company founded in 1984 by Tim Barberich. It was originally located in Princeton, New Jersey and then re-located to Marlborough, Massachusetts. On October 12, 2010, the company changed its name to Sunovion.-Company history:The company's initial focus was on the...
in America.
The European Medicines Agency
European Medicines Agency
The European Medicines Agency is a European agency for the evaluation of medicinal products. From 1995 to 2004, the European Medicines Agency was known as European Agency for the Evaluation of Medicinal Products.Roughly parallel to the U.S...
(EMA) has recommended granting marketing authorization in 2009 for adjunctive therapy
Combination therapy
Combination therapy or polytherapy is the use of more than one medication or other therapy. In contrast, monotherapy is any therapy which is taken by itself....
for partial-onset seizures, with or without secondary generalisation, in adults with epilepsy
Epilepsy
Epilepsy is a common chronic neurological disorder characterized by seizures. These seizures are transient signs and/or symptoms of abnormal, excessive or hypersynchronous neuronal activity in the brain.About 50 million people worldwide have epilepsy, and nearly two out of every three new cases...
.
The U.S. Food and Drug Administration (FDA) announced on 2 June 2009 that the drug has been accepted for filing.
Mechanism of action and indications
Eslicarbazepine acetate is a prodrug for S(+)-licarbazepine, the major active metabolite of oxcarbazepine. Its mechanism of action is therefore identical to that of oxcarbazepine.There may, however, be pharmacokinetic differences. Eslicarbazepine acetate may not produce as high peak levels of (S)-(+)-licarbazepine immediately after dosing as does oxcarbazepine which could theoretically improve tolerability.
Like oxcarbazepine, eslicarbazepine may be used to treat bipolar disorder
Bipolar disorder
Bipolar disorder or bipolar affective disorder, historically known as manic–depressive disorder, is a psychiatric diagnosis that describes a category of mood disorders defined by the presence of one or more episodes of abnormally elevated energy levels, cognition, and mood with or without one or...
and trigeminal neuralgia
Trigeminal neuralgia
Trigeminal neuralgia , tic douloureux is a neuropathic disorder characterized by episodes of intense pain in the face, originating from the trigeminal nerve. It has been described as among the most painful conditions known...
.
Patents
The first European patentPatent
A patent is a form of intellectual property. It consists of a set of exclusive rights granted by a sovereign state to an inventor or their assignee for a limited period of time in exchange for the public disclosure of an invention....
to protect this drug is . The priority of this European patent is the Portuguese patent application .