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 Cypress Bioscience, Inc. provides therapeutics and personalized medicine services to facilitate improved and individualized patient care. Cypress’ goal is to address the evolving needs of specialist physicians and their patients by identifying unmet medical needs in the areas of pain, rheumatology, and physical medicine and rehabilitation, including challenging disorders such as fibromyalgia and rheumatoid arthritis. This approach to improving patient care creates a unique partnership with physicians, and expect that offering personalized medicine services and therapeutic products through the same sales organization will provide Cypress a differentiated commercial strategy and sustainable competitive advantage. Current products include Savella® (milnacipran HCI) and the Avise PGSM and Avise MCVSM therapeutic monitoring, diagnostic and prognostic tests for rheumatoid arthritis. Savella (milnacipran HCl) Personalized Medicine Services Avise PG is a proprietary test measuring methotrexate (MTX) polyglutamates, the active metabolites of methotrexate. MTX is a widely used first line treatment for rheumatoid arthritis (RA), prescribed alone and in combination with other non-biologic and biologic therapies. Avise PG can help the physician address the needs of patients experiencing sub-optimal responses to MTX therapy, by helping to determine whether the individual patient would benefit from a higher dosage of MTX, more time on his or her current dosage of MTX, or whether metabolic factors warrant a change in the patient’s therapy. Avise MCV is a sensitive and specific personalized medicine test that improves upon traditional means of diagnosing RA. Early diagnosis and appropriate treatment of RA are critically important in the prevention of erosive joint destruction and disability. Avise MCV measures antibodies to mutated citrullinated vimentin, a protein found in the inflamed synovium of patients with RA. Elevated levels of anti MCV not only indicate an increased likelihood of having rheumatoid arthritis, but have also been shown to identify those who may develop more severe forms of RA. Avise MCV may be used for first-line diagnostic testing of patients who present with symptoms of RA, offering prognostic insight while improving diagnostic accuracy. Development Pipeline Additional information on our ongoing therapeutic clinical development
programs can be found at www.clinicaltrials.gov. |
 Savella Prescribing Information Click here for full prescribing information. (download PDF) Savella Website |
Important Safety Information for Savella Savella is a selective serotonin and norepinephrine reuptake inhibitor (SNRI), similar to some drugs used for the treatment of depression and other psychiatric disorders. Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of such drugs in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on Savella should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Savella is not approved for use in the treatment of major depressive disorder. Savella is not approved for use in pediatric patients. Savella is contraindicated in patients taking monoamine oxidase inhibitors (MAOIs) concomitantly or within 14 days of discontinuing treatment with an MAOI or in patients with uncontrolled narrow-angle glaucoma. Development of a potentially life-threatening serotonin syndrome may occur with agents that inhibit serotonin reuptake, including Savella, particularly with concomitant use of serotonergic drugs (including triptans and tramadol) and with drugs that impair metabolism of serotonin (including MAOIs). The concomitant use of Savella with serotonin precursors is not recommended. Blood pressure and heart rate should be monitored prior to initiating treatment with Savella and periodically throughout treatment. SNRIs, including Savella, have been associated with reports of increases in blood pressure and heart rate. Pre-existing hypertension, tachyarrhythmias and other cardiac diseases should be treated before starting therapy with Savella. Savella should be used with caution in patients with significant hypertension or cardiac disease. For patients who experience a sustained increase in blood pressure or heart rate while receiving Savella, either dose reduction or discontinuation should be considered. Savella should be prescribed with caution in patients with a history of a seizure disorder, mania, or controlled narrow-angle glaucoma. Savella has been associated with mild elevations of ALT and AST. Rarely, fulminant hepatitis has been reported in patients treated with milnacipran. Savella should be discontinued in patients who develop jaundice or other evidence of liver dysfunction and should not be resumed unless another cause can be established. Savella should ordinarily not be prescribed to patients with substantial alcohol use or evidence of chronic liver disease. As with other SNRIs and SSRIs, withdrawal symptoms have
been observed following discontinuation of milnacipran. A gradual dose
reduction is recommended.
Hyponatremia may occur as a result of treatment with SSRIs and SNRIs, including Savella. Discontinuation should be considered for patients with symptomatic hyponatremia.
Male patients with a history of obstructive uropathies may experience higher rates of genitourinary adverse events. Savella is unlikely to be involved in clinically significant pharmacokinetic drug interactions. Pharmacodynamic interactions of Savella with other drugs can occur.
The most frequently occurring adverse reactions (≥5% and greater than placebo) were nausea, headache, constipation, dizziness, insomnia, hot flush, hyperhidrosis, vomiting, palpitations, heart rate increased, dry mouth, and hypertension. Prescribing Information |
