Apokyn®

Apokyn® is the only therapy available in the US for the acute, intermittent treatment of immobilising “off” episodes associated with advanced Parkinson’s disease. It is administered by means of an injector pen, as needed, to treat periods of immobility in people with advanced disease.

In April 2004, Apokyn® received FDA approval with Orphan Drug designation to treat approximately 112,000 Parkinson's patients who experience the severe “on/off” motor fluctuations unresponsive to other therapies. It was launched in the US in July 2004 and acquired by Vernalis from Mylan Bertek in November 2005. Mylan Bertek originally licensed the product from Britannia Pharmaceuticals Limited in 1999. Apokyn® is now marketed by Vernalis’ newly established neurology sales force, which is focusing its promotional efforts on the high-prescribing neurologists who treat Parkinson’s disease in key US metropolitan areas.

Apokyn® is indicated for the acute, intermittent treatment of hypomobility, or ‘‘off'' episodes (end-of-dose wearing off and unpredictable “on/off” episodes) associated with advanced Parkinson's disease. "Off" episodes are debilitating periods of partial loss of movement or total immobility experienced by patients. As Parkinson's disease progresses, patients may begin to experience immobilising "off" episodes despite treatment with drugs used to increase or replace dopamine, an important brain chemical that is lost in Parkinson's disease leading to poor control of movement and muscle rigidity. Apokyn® is not used to prevent "off" episodes and it does not replace other Parkinson's disease medications, but rather is used as short-term rescue from an "off" episode when it occurs. Patients with Parkinson's disease lose motor control during "off" episodes, making routine tasks such as walking and even speaking extremely difficult. Apokyn® injections can improve function within minutes in Parkinson's disease patients, permitting them to walk, talk and perform normal activities more easily. The intensity, duration and frequency of "off" episodes vary for each sufferer. Patients with Parkinson's or their caregivers administer Apokyn® via injection under the skin.

Since Apokyn® may cause a decrease in blood pressure when first administered, initial treatment is usually conducted under medical supervision. Initial administration of Apokyn® is also associated with nausea and vomiting, so it is usual for patients to take an anti-emetic drug prior to initiating treatment. Evidence suggests, however, that these side effects diminish over time.....

Regulatory Status

Apokyn® was approved through the FDA's Orphan Drug route in April 2004 and was launched in the US in July 2004. It was marketed by Mylan Pharmaceuticals until November 2005 when it was acquired by Vernalis. For full prescribing information, please visit: www.apokyn.com .

In November 2005, Vernalis entered into a collaboration with Britannia Pharmaceuticals to explore the development of new formulations of apomorphine for the US market. Vernalis has exclusive rights to Britannia's technology to develop a continuous sub-cutaneous infusion using a small portable pump for patients with frequent fluctuations or who require multiple injections in a day and to negotiate terms for a nasal powder formulation of apomorphine, which is currently in clinical development in Europe.

http://www.vernalis.com/ver/rdc2/neurology/apokyn/