In primarily depressed patients, worsening of depression, including suicidal thoughts and actions (including completed suicides) have been reported with the use of sedative-hypnotics. Intentional overdosage is more common in this group of patients; therefore, protective measures may be required. Prescribe the least amount of Intermezzo that is feasible in these patients.
Because persons with a history of addiction to or abuse of drugs or alcohol are at increased risk for misuse, abuse, and addiction of zolpidem, they should be monitored carefully when receiving Intermezzo. Zolpidem tartrate is a Schedule IV controlled substance. Post-marketing reports of abuse, dependence, and withdrawal resulting from use of oral zolpidem tartrate have been received. Zolpidem has produced withdrawal signs and symptoms following a rapid dose decrease or abrupt discontinuation.
For additional information, please read the Intermezzo Full Prescribing Information available at http://app.purduepharma.com/xmlpublishing/pi.aspx?id=i.
About TransceptTranscept Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on the development and commercialization of proprietary products that address important therapeutic needs in the field of neuroscience. Intermezzo® (zolpidem tartrate) sublingual tablet C-IV is the first FDA approved Transcept product. Purdue holds commercialization and development rights for Intermezzo in the United States. Transcept is currently conducting a Phase 2 study of an investigational product, TO-2061, in patients with obsessive-compulsive disorder. For further information about Transcept, please visit www.transcept.com. About Purdue Pharma L.P. Purdue Pharma L.P. and its independent associated companies are privately-held pharmaceutical companies known for pioneering research on persistent pain. Headquartered in Stamford, Conn., Purdue Pharma L.P. is engaged in the research, development, production, and distribution of both prescription and over-the-counter medicines and hospital products. Additional information about Purdue Pharma L.P. can be found at www.purduepharma.com. Forward Looking Statements This press release contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, included in this press release regarding our strategy, prospects, plans and objectives of management are forward-looking statements. Examples of such statements include, but are not limited to, statements relating to the potential for Intermezzo to make a meaningful difference for many patients and to be a commercial success. Transcept and/or Intermezzo may not actually meet the expectations or projections disclosed in our forward-looking statements, and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions, expectations and projections disclosed in the forward-looking statements. Various important factors could cause actual results or events to differ materially from the forward-looking statements that Transcept makes, include, but are not limited to, the following: achieving acceptance of Intermezzo by physicians, patients and third party payors; supplying sufficient quantities of Intermezzo from third party manufacturers and suppliers to meet anticipated market demand; the impact of competitive products and the market for Intermezzo generally; our dependence on our collaboration with Purdue; and obtaining, maintaining and protecting regulatory exclusivity and intellectual property protection for Intermezzo. These and other risks are described in greater detail in the "Risk Factors" section of Transcept's Annual Report on Form 10-K filed on March 30, 2012 and other periodic reports filed with the SEC. Forward-looking statements do not reflect the potential impact of any future in-licensing, collaborations, acquisitions, mergers, dispositions, joint ventures, or investments Transcept may enter into or make. Transcept does not assume any obligation to update any forward-looking statements. Contact Information Greg MannTranscept Pharmaceuticals, Inc.510-215-3567 firstname.lastname@example.org SOURCE Transcept Pharmaceuticals, Inc.
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