AOP Orphan Pharmaceuticals AG announced today the regulatory submission of Tetrabenazine for the treatment of tardive dyskinesia in a DCP (decentralized procedure) for several European countries with UK being reference member state.
Tardive dyskinesia (TD) is a chronic movement disorder caused by prolonged exposure to medications that block dopamine receptors, including antipsychotic drugs and some drugs used to treat nausea. It is characterized by involuntary, repetitive movements that usually involve the face and in more severe cases affect the trunk and/or extremities. Involuntary movements of the lips, cheeks, tongue and jaw are typical. The disorder is irreversible in the majority of cases.
"The opportunity to bring relief to the many patients who face the debilitating effects of movement disorders and suffer from the effects of conditions such as tardive dyskinesia is greatly needed and humbling," said Dr. Rudolf Widmann, CEO and founder of AOP Orphan.
"Within AOP Orphan, we have a rich history in building relationships with patients and physicians to match treatments to those affected with CNS disorders," said Georg Fischer, MD, Board Member and Business Development Director at AOP Orphan. "People living with movement disorders and those around them often need support and services beyond medication. We have the infrastructure, existing strong relationships with neurologists, therapeutic expertise in CNS and passion in place to assist them."
Tetrabenazine is marketed in a number of countries, including Austria, Denmark, France, Germany, Ireland, Portugal, the United Kingdom, as well as in several Central Eastern European territories. Tetrabenazine is approved for treatment of chorea associated with Huntington's disease (HD). Huntington's disease is a rare inherited neurological disorder. The disease results from genetically programmed degeneration of brain cells. The deterioration causes uncontrolled movements, loss of intellectual faculties, and emotional disturbance.
Tetrabenazine decreases the amount of dopamine available to work at relevant synapses in the brain. Dopamine is a chemical that communicates between certain nerve cells in the brain. In patients with Huntington's disease, this system is overactive and results in the abnormal movements called chorea. Tetrabenazine decreases the amount of dopamine available to interact with certain nerve cells, thereby decreasing the involuntary movements.
Tetrabenazine is a presynaptic dopamine depletor that may have considerable efficacy in tardive kyskinesia (TD), especially tardive dystonia, tics associated with Tourette’s syndrome, dystonia, other choreas, and facial dystonia/dyskinesia (2).
Important Safety Information
The most frequent adverse events reported with Tetrabenazine include sedation/somnolence, fatigue, insomnia, depression, akathisia and nausea. Tetrabenazine can increase the risk of depression and suicidal thoughts and behavior (suicidality) in patients with Huntington’s disease and the drug is therefore contraindicated in patients who are actively suicidal, and in patients with untreated or inadequately treated depression. Tetrabenazine is also contraindicated in patients with impaired hepatic function and in patients taking monoamine oxidase inhibitors or reserpine.
About AOP Orphan
AOP Orphan was one of the first companies to enter the sector of Rare Diseases in Europe and continues to be at the vanguard of Orphan Diseases to this day. As a specialist Rare Diseases company AOP Orphan researches, produces and sells innovative solutions, focusing on: hematology and oncology, cardiology and pulmonology, and neurology and psychiatry. AOP Orphan is active internationally with an export ratio of 70% and is one of the leading players in the Orphan Drug market.
1. Tetmodis. Prescribing Information.
2. Jack J. Chen et al. Tetrabenazine for the treatment of hyperkinetic movement disorders: a Review of the Literature. Clinical Therapeutics July 2012; 34(7):1487-1504.
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