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://www.purduepharma.com/IntermezzoPI.
Conference call and webcast informationTranscept will host a conference call and webcast on Tuesday, November 27, 2012, at 8:30 a.m. ET to discuss the broadened Intermezzo® commercialization strategy and direct to consumer advertising campaign. Telephone numbers for the live conference call are 877-638-4558 (U.S.) or 914-495-8537 (International). The webcast can be accessed on the Investors page of the Transcept website at www.transcept.com and will be available for replay until close of business on January 30, 2013.About Transcept PharmaceuticalsTranscept 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 Pharma 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. For information about Intermezzo, please visit www.IntermezzoRx.com. Forward looking statementsThis 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, future operations, future financial position, future revenues, projected expenses, prospects, plans and objectives of management are forward-looking statements. Examples of such statements include, but are not limited to, statements relating to the following: plans by Purdue and Transcept to launch and fund a consumer advertising campaign for Intermezzo; the nature, effectiveness, results and expected duration of a consumer advertising campaign for Intermezzo, and the parties' expectations as to the size and expected timing of such a campaign; Purdue's commitment to increasing awareness of Intermezzo; the importance of Intermezzo in addressing significant medical needs, including those related to insomnia; and the availability of Intermezzo to insomnia patients. Transcept may not actually achieve the plans, carry out the intentions or 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, including 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; obtaining, maintaining and protecting regulatory exclusivity and intellectual property protection for Intermezzo; and the ability of Transcept to obtain additional funding, if needed, to support its business activities. These and other risks are described in greater detail in the "Risk Factors" section of the Transcept Quarterly Report on Form 10-Q filed with the SEC on November 13, 2012 and Annual Report on Form 10-K filed with the SEC on March 30, 2012. 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, except as required by law. Contact: Transcept Pharmaceuticals, Inc. Greg Mann Sr. Director, Corporate Communications (510) 215-3567 firstname.lastname@example.org SOURCE Transcept Pharmaceuticals, Inc.