INTRA-CELLULAR THERAPIES, INC. CAPLYTA is an oral, once daily medicine approved for the treatment of schizophrenia in adults.
A national CAPLYTA launch meeting, which included the Company's full sales force and its entire commercial leadership team, was held during the week of
'I am proud of our successful execution of a full virtual launch and the array of activities we have developed to support the launch of CAPLYTA,' said Dr.
The LYTAlink program offerings consist of coverage and reimbursement services, out-of-pocket copay support for commercially insured patients, medication compliance communications, and patient assistance relief specifically for those without insurance. LYTAlink is designed to be the link between CAPLYTA and the eligible schizophrenia patients who may benefit from this program.
Mental health community services and resources are extremely important as the country addresses the impact of the COVID-19 crisis. The efforts of the mental health advocacy community in bringing important educational resources and raising emerging policy concerns into the national, state, and local response is to be commended.
CAPLYTA (lumateperone) is indicated for the treatment of schizophrenia in adults. CAPLYTA is available in 42 mg capsules.
About CAPLYTA (lumateperone)
CAPLYTA is an oral, once daily medicine approved for the treatment of schizophrenia of adults (42mg/day).
The mechanism of action of CAPLYTA in the treatment of schizophrenia is unknown. However, the efficacy of CAPLYTA could be mediated through a combination of antagonist activity at central serotonin 5-HT2A receptors and postsynaptic antagonist activity at central dopamine D2 receptors.
CAPLYTA is being developed for the treatment of bipolar depression, behavioral disturbances in patients with dementia, including Alzheimer's disease, depression and other neuropsychiatric and neurological disorders. CAPLYTA has not been demonstrated to be safe and effective in these other areas.
About
Forward-Looking Statements
This news release contains 'forward-looking statements' within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainties that could cause actual results to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. Such forward-looking statements include statements regarding, among other things, our expectations regarding our commercialization of CAPLYTA, including the impact of COVID-19 on the commercialization of CAPLYTA and the promotional efforts we expect to utilize in support of the product; our goal to provide healthcare providers with comprehensive education on CAPLYTA; the ability for LYTAlink to be the link between CAPLYTA and the eligible schizophrenia patients who may benefit from this program; and our beliefs about the potential utility of our product candidates; and development efforts and plans under the caption 'About Intra-Cellular Therapies.' All such forward-looking statements are based on management's present expectations and are subject to certain factors, risks and uncertainties that may cause actual results, outcome of events, timing and performance to differ materially from those expressed or implied by such statements. These risks and uncertainties include, but are not limited to, the following: there are no guarantees that CAPLYTA will be commercially successful; we may encounter issues, delays or other challenges in launching or commercializing CAPLYTA; the COVID-19 pandemic may negatively impact our commercial plans and sales for CAPLYTA; the COVID-19 pandemic may negatively impact the conduct of, and the timing of enrollment, completion and reporting with respect to, our clinical trials, whether CAPLYTA receives adequate reimbursement from third-party payors; the degree to which CAPLYTA receives acceptance from patients and physicians for its approved indication; challenges associated with execution of our sales activities, which in each case could limit the potential of our product; results achieved in CAPLYTA in the treatment of schizophrenia once we have launched the product may be different than observed in clinical trials, and may vary among patients; any other impacts on our business as a result of or related to the COVID-19 pandemic; risks associated with our current and planned clinical trials; we may encounter unexpected safety or tolerability issues with CAPLYTA for the treatment of schizophrenia or in ongoing or future trials and other development activities; our other product candidates may not be successful or may take longer and be more costly than anticipated; product candidates that appeared promising in earlier research and clinical trials may not demonstrate safety and/or efficacy in larger-scale or later clinical trials; our proposals with respect to the regulatory path for our product candidates may not be acceptable to the
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