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EU OKs Nuedexta for PBA
Avanir Pharmaceuticals, Inc. today announced that the European Commission has approved NUEDEXTA® (dextromethorphan hydrobromide/quinidine sulfate) in the European Union for the treatment of pseudobulbar affect (PBA), irrespective of underlying neurologic disease or injury.
http://www.pharmalive.com/avanir-pharmaceuticals-announces-european-approval-of-nuedexta
NUEDEXTA is an oral formulation of dextromethorphan hydrobromide USP and quinidine sulfate USP in a fixed dose combination.
Dextromethorphan hydrobromide is the pharmacologically active ingredient of NUEDEXTA that acts on the central nervous system (CNS). The chemical name is dextromethorphan hydrobromide: morphinan, 3-methoxy-17-methyl-, (9α, 13α, 14α)- hydrobromide monohydrate. Dextromethorphan hydrobromide has the empirical formula C18H25NO•HBr•H2O with a molecular weight of 370.33. The structural formula is:

Quinidine sulfate is a specific inhibitor of CYP2D6-dependent oxidative metabolism used in NUEDEXTA to increase the systemic bioavailability of dextromethorphan. The chemical name is quinidine sulfate: cinchonan-9-ol, 6’-methoxy- (9S) sulfate (2:1), (salt), dihydrate. Quinidine sulfate dihydrate has the empirical formula of (C20H24N2O2)2•H2SO4•2H2O with a molecular weight of 782.96. The structural formula is:

The combination product, NUEDEXTA, is a white to off-white powder. NUEDEXTA is available for oral use as NUEDEXTA which contains 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate. The active ingredients are dextromethorphan hydrobromide monohydrate USP and quinidine sulfate dihydrate USP.Inactive ingredients in the capsule are croscarmellose sodium NF, microcrystalline cellulose NF, colloidal silicon dioxide NF, lactose monohydrate NF, and magnesium stearate NF.
European Medicines Agency recommends approval of first treatment for pseudobulbar affect
26/04/2013
Dextromethorphan
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Quinidine
European Medicines Agency recommends approval of first treatment for pseudobulbar affect
Medicine to help curb bouts of uncontrolled emotional expression in patients with certain neurological disorders
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended the granting of a marketing authorisation for Nuedexta, a medicine for the treatment of pseudobulbar affect in adults.
Pseudobulbar affect is a medical condition in which patients experience sudden and uncontrollable bouts of laughing or crying unrelated or disproportionate to their emotional state. It occurs when certain neurological disorders, such as multiple sclerosis (MS) and amyotrophic lateral sclerosis (ALS) or a stroke, damage areas of the brain that are involved in the control of normal expression of emotion. This damage can disrupt brain signalling, resulting in the alteration or loss of control of emotional expression.
Although pseudobulbar affect is a non-life-threatening condition, it can have a significant impact on an individual’s ability to interact normally in society and on their relationships with others. There is currently no treatment approved for pseudobulbar affect in the European Union.
Nuedexta is a combination of two known active substances, dextromethorphan hydrobromide and quinidine sulphate. In studies, treatment with these medicines significantly decreased episodes of involuntary, uncontrollable laughing or crying.
Pseudobulbar affect is observed in a number of neurological conditions. Nuedexta has currently only been studied in patients with MS and ALS. Nuedexta is not suitable for treating episodes of laughing or crying brought on by mood swings and not due to pseudobulbar affect.
The CHMP’s opinion on Nuedexta will now be sent to the European Commission for the adoption of a marketing authorisation.
Note
- The marketing authorisation holder for Nuedexta is Jenson Pharmaceutical Services Ltd.
Dextromethorphan/quinidine (trade name Nuedexta) is a combination drug containing the active ingredients dextromethorphan and quinidine. It was the first FDA-approved drug for the treatment of pseudobulbar affect (PBA).
In a 12 week randomized, double-blind trial, amyotrophic lateral sclerosis and multiple sclerosis patients with significant PBA were given either Nudexta 30/10 mg or placebo. In 326 randomized patients, the PBA-episode daily rate was 46.9% (p < 0.0001) lower for Nudexta than for placebo.
Nuedexta was approved in February 2011 and is marketed in the United States by Avanir Pharmaceuticals.
DRUG APPROVALS BY DR ANTHONY MELVIN CRASTO
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