clobazam Oral suspension 1 mg/ml, 2 mg/ml - 150 ml, 250 ml

Dossier type
EU CTD
Dossier status
Ready to file
Country of origin
European Union
GMP approvals
EU GMP
Manufacturer #15084
This European pharmaceutical company specializes in the Central Nervous System (CNS) and Hospital Injectables. They operate in a niche market focusing on treatments for debilitating conditions like chronic pain and addiction. With a strong commitment to patient care, they are actively seeking new opportunities to expand their product portfolio and geographical reach, particularly within the EU market. Their core therapy areas include CNS disorders, pain management, and addiction treatment. The company has a robust research and development (R&D) program and actively seeks strategic partnerships to further its growth. This company develops and produces both prescription and over-the-counter (OTC) medications in various dosage forms, including injectables, solids, and liquids, which are manufactured under EU and other GMP standards. They hold numerous patents for their innovative drug formulations and have a track record of successful acquisitions, demonstrating their commitment to expanding their presence in the pharmaceutical industry. This company has a solid presence in the European market with an expansion into the Asia region, and is actively pursuing opportunities to expand its global footprint.

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Clobazam

Clobazam is a medicine from the benzodiazepine class. Clobazam is used for its anxiolytic effect, and as adjunctive therapy in epilepsy. In Canada, it is used as adjunctive therapy in the treatment of complex partial seizures, status epilepticus like a myoclonic, myoclonic-absent, simple partial, complex partial, tonic, non-status absence seizures, and for the treatment of anxiety. Clobazam is sold under the brand name Frisium among others. Boehringer Ingelheim GmbH was awarded the patented for Clobazam in 1968. It has been used since 1970 as an enantioselective anxiolytic and since 1984, as an anticonvulsant. Clobazam's development goal was to find better alternatives to benzodiazepine and provide better anxiolytic, anti-obsessive effects, and fewer benzodiazepine-related side effects. In 2011, the FDA approved an oral preparation and an oral suspension in 2013.

Dosage Forms & Strengths

Clobazam is a Schedule IV drug and sold as a scored tablet in 10mg and 20mg strengths. Its oral suspension has 2.5mg/mL and the oral soluble film has doses from 5mg to 20mg. In the treatment of Seizures, it is used for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome. The initial dose for treatment starts at 5 mg taken orally every 12 hours and the dose can titrate as tolerated up to 40 mg a day, divided into doses taken 12 hours apart. The dose increase should not be done more than once a week. In children, the initial dose is 5 mg per day and titrated according to weight, but maintained at half the adult dose. If needed, additional titration to the maximum dose of 20 mg per day or 40 mg per day is done depending on the weight group and is started on day 21 of the therapy.

The price of Clobazam

In the USA, the consumer pays an average retail price of $823.20 for a generic 60 tablet of 10mg strength. This medicine is much cheaper in the developing parts of the world, where the costs are down due to local manufacturing of the generic version. In India, a supply of 60 tablets of 10mg, costs around USD 1.2.

How does Clobazam work?

Clobazam's actions are not fully understood. However, it has been postulated that it is involved in the potentiation of GABAergic neurotransmission. This is an outcome of binding at the benzodiazepine site at the GABA(A) receptor. It has the ability to bind at distinct binding sites associated with the chloride ionophore at the post-synaptic GABA receptor in various locations in the CNS. Here clobazam increases the length of time for which the chloride ionophore stays open. As the postsynaptic inhibitory effect of GABA increases, these series of actions result in hyperpolarization and stabilization of the membrane.

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