Forest Laboratories, Inc., has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for cariprazine, a potent dopamine D3/D2 receptor partial agonist with preferential binding to D3 receptors. Cariprazine was discovered by Gedeon Richter Plc and is licensed to Forest Laboratories Inc., in the US and Canada.
The application for the treatment of schizophrenia includes results from three positive trials in over 1700 patients, two fixed dose studies with active controls and one fixed-flexible placebo-controlled dose study using the change from baseline in Positive and Negative Syndrome Scale (PANSS) total score as primary efficacy endpoint.
The application for the acute treatment of manic or mixed episodes associated with Bipolar I Disorder includes results from three positive placebo-controlled trials in over 1000 patients, two flexible dose studies and one fixed-flexible dose study using the change from baseline in the Young Mania Rating Scale (YMRS) total score as primary efficacy endpoint.
In the schizophrenia and bipolar mania pivotal trials, cariprazine was generally well tolerated. The most commonly reported adverse reactions (= five per cent and twice placebo), which were predominantly mild to moderate in severity, were akathisia, extrapyramidal disorder, dyspepsia, restlessness, tremor, fatigue and vomiting.
Schizophrenia is a chronic and disabling disorder which imposes significant burden on patients, their families, and society. Symptoms fall into three broad categories: positive symptoms (hallucinations, delusions, thought disorders, and movement disorders), negative symptoms (such as loss of motivation and social withdrawal), and cognitive symptoms (problems with executive functioning, focusing, and working memory).
Bipolar I disorder, also known as manic-depressive illness, is characterized by unusual shifts in mood, energy, activity levels, and the ability to carry out day-to-day tasks. Patients experience "mood episodes" which manifest as either a manic episode (overexcited, extreme irritability, racing thoughts, and difficulties with sleep) or a depressive episode (extreme sadness, fatigue or hopelessness) or a combination of both.
Cariprazine is an orally active and potent dopamine D3-preferring D3/D2 receptor partial agonist. Cariprazine has a low affinity at other receptor sites such as 5-HT2C, muscarinic, and adrenergic which have been associated with adverse events.
Gedeon Richter is a major pharmaceutical company in Central Eastern Europe, with an expanding direct presence in Western Europe. The product portfolio of the Company covers almost all important therapeutic areas, including gynecology, central nervous system and cardiovascular.
Forest Laboratories’ longstanding global partnerships and track record developing and marketing pharmaceutical products in the United States have yielded its well-established central nervous system and cardiovascular franchises and innovations in anti-infective and respiratory, gastrointestinal, and pain management medicine. The Company’s pipeline, the most robust in its history, includes product candidates in all stages of development across a wide range of therapeutic areas.