Transcept Pharmaceuticals (Nasdaq: TSPT) announced that the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter regarding the New Drug Application (NDA) for Intermezzo® (zolpidem tartrate sublingual tablet). The NDA, submitted by Transcept in September 2008, seeks approval to market Intermezzo® for use as-needed for the treatment of insomnia when a middle of the night awakening is followed by difficulty returning to sleep.

In the Complete Response Letter the FDA stated that it believes Transcept has submitted substantial evidence of effectiveness for the use of Intermezzo® in the as-needed treatment of insomnia characterized by difficulty returning to sleep after awakening in the middle of the night. The FDA further recognized that the Intermezzo® data submitted by Transcept did not indicate significant next day residual effects. However, the FDA indicated that the intended use of Intermezzo® in the middle of the night represents a unique insomnia indication and dosing strategy for which safety has not been previously established.

The FDA requested additional data demonstrating that Intermezzo®, when taken as directed in the middle of the night, would not present an unacceptable risk of residual effects, with particular reference to next day driving ability.

The FDA also expressed two concerns regarding the possibility of patient dosing errors in the middle of the night that could lead to next day residual effects. Specifically, the FDA has asked Transcept to address methods to avoid inadvertent dosing with less than four hours of bedtime remaining, and inadvertent re-dosing in a single night.

Based upon the content of the letter, it is possible that Transcept will need to conduct one or more additional safety studies. Transcept will request a meeting with the FDA to discuss specific requirements for approval.

Glenn A. Oclassen, President and Chief Executive Officer of Transcept, commented, “Transcept is committed to making this important new potential therapy available to insomnia patients. We will continue to work closely with the FDA to address their questions and define the path forward for Intermezzo®.”

About Intermezzo®

Intermezzo® (zolpidem tartrate sublingual tablet), the lead product candidate at Transcept, has the potential to be the first prescription sleep aid specifically approved for use in the middle of the night at the time a patient awakens and has difficulty returning to sleep. Intermezzo® is a sublingual low dose formulation of zolpidem, the active agent most commonly prescribed in the United States for the treatment of insomnia. Intermezzo® uses approximately one-quarter to one-third of the dose of active drug contained in currently marketed zolpidem-based sleep aids, in a formulation designed to promote rapid sublingual absorption.

Two Phase 3 clinical studies evaluated 376 patients receiving either Intermezzo® or placebo. In the first study, a sleep laboratory trial using an objective polysomnographic endpoint, Intermezzo® demonstrated a statistically significant decrease versus placebo in the time it took patients to return to sleep as measured by Latency to Persistent Sleep. In the second study, an outpatient trial, Intermezzo® demonstrated a statistically significant decrease in Latency to Sleep Onset, a subjective patient reported endpoint. The most common adverse event seen in these trials was headache (2.7 percent active versus 1.4 percent placebo in the outpatient study).

Transcept is actively pursuing patents to protect Intermezzo® in the United States and key non-U.S. markets, and, as part of the NDA submission, has requested that the FDA grant three years of Hatch-Waxman marketing exclusivity to Intermezzo®.

About Transcept

Transcept Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on the development and commercialization of proprietary products that address important therapeutic needs in neuroscience. The most advanced Transcept product candidate is Intermezzo® (zolpidem tartrate sublingual tablet), which is currently being reviewed by the U.S. Food and Drug Administration (FDA) as a prescription sleep aid for use in the middle of the night at the time a patient awakens and has difficulty returning to sleep. Transcept and Purdue Pharmaceutical Products, L.P. have entered into a collaboration agreement for the development and commercialization of Intermezzo® in the United States.

Forward Looking Statements

This press release contains forward looking statements for purposes of the Private Securities Litigation Reform Act of 1995 (the Act). Transcept disclaims any intent or obligation to update these forward-looking statements, and claims the protection of the safe harbor for forward-looking statements contained in the Act. Examples of such statements include, but are not limited to, the sufficiency of data submitted and data that may be generated and submitted in support of the NDA for Intermezzo® to receive FDA approval for its intended indication, including whether or not additional clinical or non-clinical studies will be required to obtain FDA approval; the timing and potential outcome of regulatory decisions by the FDA on the NDA for Intermezzo®; the commitment of Transcept to make Intermezzo® available to insomnia patients; and the potential for Intermezzo® to be the first prescription sleep aid specifically approved by the FDA for use in the middle of the night at the time a patient awakens and has difficulty returning to sleep. Such statements are based on management’s current expectations, but actual results may differ materially due to various risks and uncertainties, including, but not limited to, whether additional data exists or can be generated from existing or new clinical studies to demonstrate sufficiently to the FDA that Intermezzo® would not present an unacceptable risk of residual effects, including residual effects that impair next day driving ability; whether Transcept can sufficiently demonstrate to the FDA that it can reduce dosing errors in the middle of the night or that dosing errors will not lead to unacceptable next day residual effects; FDA decisions on the sufficiency of other data submitted in support of the Intermezzo® NDA to receive approval for its intended indication and any further delays in, and the final form of, any FDA approval of Intermezzo®; a decision by Purdue to terminate the Collaboration Agreement, even if the Intermezzo® NDA is approved; obtaining and maintaining Hatch-Waxman exclusivity for Intermezzo®, obtaining and maintaining patents that provide market place protection for Intermezzo® and other difficulties or delays in, clinical development, market acceptance and commercialization of Intermezzo®.

Source: Transcept Pharmaceuticals, Inc

Natural Insomnia RemediesThere is an unfortunate number of borrowers who have from insomnia and chronic insomnia these days. A lot of people find respite over medication, though possibly currently is not the best cure. Thankfully, there are innate ways of curing insomnia which will leave you able to sleep ideal and be healthier without becoming addicted to sleeping pills. Insomnia usually has a distinct cause behind it, though it may be different for each person. Common causes of insomnia are over consumption of caffeine, lack of proper nutrition and exercise, stress, or a bad sleeping environment. All of these causes are easy to correct. If you are an avid coffee or tea drinker, limit your cups to just one or two per day. Furthermore, avoid drinking anything caffeinated within four to five hours of bedtime. Pay attention to when you eat. If you eat very near your bedtime, your body will still be working on digestion and will not be able to settle into sleep. Try eating your last meal several hours before bedtime, and learn what works best for your body so you are neither too full nor too hungry when you are ready to sleep. Another practical cure for insomnia is to schedule a consistent bedtime and wake up time every day. A slight change of a half hour or so is not a problem, but when you go to sleep and get up at varied times throughout the week, your body is never able to fully understand when it should be awake and when it should be sleeping. Many people who do not eat a balanced diet or participate in frequent exercise suffer from insomnia. Food plays an important role in how well you sleep, and it is known that those who eat nutritiously have better sleep habits over all. Exercise is essential in getting a good nights sleep as well and can reduce chronic pain or discomfort which may also affect your rest. If you think your insomnia may be caused by stress, trying incorporating stress reducers into your evening routine. You might try Yoga, a warm bath, or reading a good book by candle light. Light stretching, quiet music, or a back rub can also help the body settle down. Finally, you may suffer from insomnia simply because of the bedroom or bed on which you sleep. Make sure you have a comfortable mattress, a pillow that gives the proper support, and blankets enough to keep you warm. Be sure the room is dark enough, free of stress inducing items, and the proper temperature. Do your body a favour. Have a good sleep tonight! Download your Natural Insomnia Remedies eBook now!

What are Your Choices of Snoring Devices

Sleep is said to consume a third of our lives. The other two-thirds is spent on busy waking hours.

While we all hope for having regular restful sleep, a number of sleep disorders impede us from doing so. Among the most common culprits of our deprived sleep is snoring.

Snoring is the sound created during sleep. While we literally breathe during the whole day, this sound can only be produced once the body is at its restful position. The sounds are products of the collapsible parts in the throat that collides as air runs through them. Depending on the speed of the wind, the intensity of collision and the bulk of tissues dangling on this passage, the frequency and quality of snores vary.

Sleep is the only state where we can actually feel peaceful about ourselves. If some dangling muscles would prevent us from having rest, then we must find ways to eliminate the factors that lead to our sleep deprivation.

There are about three hundred anti snoring devices patented at the present. However, the varieties and the number of individual manufacturers using the ideas of these devices are innumerable. Thus, it is impossible for you not to find one that would suit your preferences.

Some of the most typical stop snoring devices are discussed here. We would provide you brief information on each product.

Stop Snoring Rings.  Seems to be an unlikely solution to the problem of snoring.  How can the wearing of a simple ring on your finger possibly stop snoring? When correctly positioned, it gives slight pressure to one of the meridian lines in your little finger. thereby using the age old principal of accupressure, and preventing you from snoring.

Adjustable beds. Sleep would never be comfortable without a bed to lay your body on. And what bed is more comfortable for snorers but the one especially designed for them? Most adjustable beds have an elevation of 30 degrees from the ground. It has been studied that this elevation would keep your tongue from sliding towards the throat and your jaw from dropping inappropriately. Thus, eliminating the possibilities of creating blockages in the air passage.

Dental appliances are also commonly advised to provide relief. There are various types of dental appliances that a snorer can use. However, there are too few that truly work for most users. Mandibular Advancement Appliances provides more comfort, durability and adaptability to one’s jaw since they are custom made. Nevertheless, such products can also be bought over-the-counter. Other dental appliances such as tongue-retaining flange and tongue retaining devices do not allow snorers to swallow comfortably. Therefore, these are not usually reported to work at their best.

There are simpler snoring devices such as stop snoring pillows and nasal breathing equipments.

Stop snoring pillows normally have mechanisms that encourage a person to sleep on his side. Sleeping on one’s back is known to induce snoring since the lower jaw is allowed to drop while creating a space where the tongue can fall back. This can also constrict the air passage, which narrows the canal through which the air can flow.