Transcept Pharmaceuticals Announces FDA Approval of IntermezzoÂ® (zolpidem tartrate sublingual tablet) C-IV For Use as Needed for the Treatment of Insomnia When a Middle-of-the-Night Awakening is Followed by Difficulty Returning to Sleep
Point Richmond, Calif., Nov. 23, 2011 /PRNewswire/ –Transcept Pharmaceuticals, Inc. (Nasdaq: TSPT) announced today that the U.S. Food and Drug Administration (FDA) has approved IntermezzoÃ‚® (zolpidem tartrate sublingual tablet)( )C-IV for use as needed for the treatment of insomnia when a middle-of-the-night awakening is followed by difficulty returning to sleep. Intermezzo is not indicated for the treatment of middle-of-the-night insomnia when the patient has fewer than 4 hours of bedtime remaining before the planned time of waking.
Middle-of-the-night awakening with difficulty falling back to sleep is a form of insomnia that is estimated to affect millions of adults in the United States.(1) Intermezzo is the first and only prescription sleep aid indicated for dosing in the middle of the night to treat this form of insomnia.
Intermezzo is formulated as a sublingual tablet containing a bicarbonate-carbonate buffer. Intermezzo is rapidly absorbed in both women and men. The recommended dose of Intermezzo for non-elderly patients is 1.75 mg for women and 3.5 mg for men, taken only once per night as needed if a middle-of-the-night awakening is followed by difficulty returning to sleep. These recommended doses are specific to each gender because women clear zolpidem from the body at a lower rate than men. The 1.75 mg dose is recommended for patients over the age of 65. The recommended doses of other FDA approved zolpidem products range between 5 mg and 12.5 mg and are indicated for bedtime use.
The safety and efficacy of Intermezzo were evaluated in two placebo-controlled studies for the treatment of patients with insomnia characterized by difficulty returning to sleep after awakening in the middle of the night. In both a sleep laboratory study and an outpatient study, treatment with Intermezzo after a middle-of-the-night awakening helped patients return to sleep significantly faster than placebo. The most commonly reported adverse reactions in these studies were headache, nausea and fatigue.(2)
Transcept has agreed to FDA post-marketing commitments including a study of patient compliance with Intermezzo dosing instructions and pediatric use assessment in accordance with the Pediatric Research Equity Act (PREA).
Transcept and Purdue are parties to a collaboration agreement for the development and commercialization of Intermezzo in the United States. Under this collaboration agreement, Purdue has until December 8, 2011 to notify Transcept whether it will proceed with the commercialization of Intermezzo.
IntermezzoÃ‚® (zolpidem tartrate sublingual tablet) C-IV is indicated for use as needed for the treatment of insomnia when a middle-of-the-night awakening is followed by difficulty returning to sleep. Intermezzo is not indicated for the treatment of middle-of-the-night insomnia when the patient has fewer than 4 hours of bedtime remaining before the planned time of waking.
Intermezzo is formulated as a sublingual tablet that contains a bicarbonate-carbonate buffer and is intended to be placed under the tongue where it is allowed to disintegrate completely before swallowing. Intermezzo is available in doses of 1.75 mg and 3.5 mg.
Important Safety Information
Intermezzo is contraindicated in patients with known hypersensitivity to zolpidem. Observed reactions with zolpidem include anaphylaxis and angioedema.
Intermezzo, like other sedative-hypnotic drugs, has central nervous system (CNS) depressant effects. Co-administration with other CNS depressants (e.g., benzodiazepines, opioids, tricyclic antidepressants, alcohol) increases the risk of CNS depression.
The failure of insomnia to remit after 7 to 10 days of treatment may indicate the presence of a primary psychiatric and/or medical illness that should be evaluated.
Angioedema, and additional symptoms suggesting anaphylaxis, may occur in patients taking Intermezzo and may be fatal. Patients who develop angioedema or anaphylaxis after treatment with zolpidem should not be re-challenged with Intermezzo.
Abnormal thinking and behavior changes have been reported to occur in association with the use of sedative-hypnotics, including decreased inhibition, bizarre behavior, agitation, and depersonalization, as well as visual and auditory hallucinations. Complex behaviors such as “sleep-driving” and “sleep-eating,” with amnesia for the event, have been reported with sedative-hypnotics. The use of alcohol and other CNS depressants with zolpidem appears to increase the risk of such behaviors. Discontinuation of zolpidem should be strongly considered for patients who report a sleep-driving episode. The emergence of any new behavioral sign or symptom of concern requires careful and immediate evaluation.
In primarily depressed patients, worsening of depression, including suicidal thoughts and actions (including completed suicides), has been reported in association with the use of sedative-hypnotics. Suicidal tendencies may be present in such patients and protective measures may be required. Intentional over-dosage is more common in this group of patients; therefore, the lowest number of tablets that is feasible should be prescribed for the patient at any one time.
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 classified as a Schedule IV controlled substance by federal regulation. Post-marketing reports of abuse, dependence, and withdrawal resulting from the use of oral zolpidem tartrate have been received. There have been reports of withdrawal signs and symptoms following the rapid dose decrease or abrupt discontinuation of zolpidem.
Intermezzo should only be taken in bed. Intermezzo is not indicated for the treatment of middle-of-the-night insomnia when the patient has fewer than 4 hours of bedtime remaining before the planned time of waking. Patients should not drive or undertake other dangerous activities after taking Intermezzo until they are fully awake. Patients should be cautioned about possible combined effects with CNS-depressant drugs. Intermezzo should not be taken with alcohol.
To view the full prescribing information please visit: www.transcept.com.
About Transcept Pharmaceuticals
Transcept 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) is the first FDA approved Transcept product and is indicated for use as needed for the treatment of insomnia when a middle-of-the-night awakening is followed by difficulty returning to sleep. Transcept and Purdue have entered into a collaboration agreement for the development and commercialization of Intermezzo in the United States.
Transcept is currently conducting a Phase 2 study of TO-2061, a low dose ondansetron augmentation therapy for patients with obsessive compulsive disorder (OCD) who have not adequately responded to treatment with approved first-line pharmacotherapy. For further information, please visit the Transcept website at: www.transcept.com.
Conference Call and Webcast Information
Transcept will host a conference call and webcast on Wednesday, November 23, 2011, at 2:30 p.m. ET to discuss the FDA approval of Intermezzo. 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 December 31, 2011. A playback of the call will be available through November 30, 2011, by dialing 855-859-2056 (U.S.) or 404-537-3406 (International), replay ID: 30305793.
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, 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: the expected timing for when Transcept would receive notice from Purdue about whether it plans to commercialize Intermezzo, expectation that Intermezzo will be launched successfully in the United States and Transcept plans to continue to develop other important medications that can address therapeutic needs in the field of neuroscience. 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, include, but are not limited to, the following: Purdue continuing with our Intermezzo collaboration; achieving product acceptance 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; 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 successfully develop or acquire additional pharmaceutical product candidates or products. These and other risks are described in greater detail in the “Risk Factors” section of Transcept 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.
Director, Corporate Communications
Transcept Pharmaceuticals, Inc.
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SOURCE Transcept Pharmaceuticals, Inc.