Carlsbad, CA – June 12, 2006 – Next Pharmaceuticals, Inc. (NPI) announced today the results of a new study that demonstrates that Seditol®, a proprietary blend of botanical ingredients is a safe and effective formulation that helps promote a good night’s sleep. The study of more than six-hundred participants concluded that Seditol® provides relaxation, promotes restful sleep and helps reduce fatigue due to lack of sleep with minimal side effects
“We are very excited as well as heartened by the results of this study, said Bob Garrison, R.Ph, CEO and President of NPI. “Sleep issues are experienced by more than 70 million Americans, many of whom are looking for a natural approach to getting a good night’s sleep. The study confirms that Seditol® is safe and effective and will help a lot of people who are very tired of being tired.”
The study was conducted at the Living Longer Clinic in Cincinnati, Ohio and the Principal Investigator was Jim LaValle, R.Ph., N.M.D., C.C.N. The primary objective was to study the safety and efficacy of Seditol® while measuring its effects on quality of sleep. The product was administered one hour before bedtime for a minimum of fourteen days. The patients were also given the opportunity to note anything they disliked about Seditol®. A total of 618 subjects completed the study. It was designed to be an open label, single center, clinical trial involving a minimum of five hundred subjects who are patients of the clinic and reported having trouble falling asleep or staying asleep. Ninety-two percent of the subjects reported Seditol® helped them relax; 88% reported Seditol® helped them have a restful night’s sleep; and 89% reported Seditol® helped reduce fatigue due to lack of sleep.
Safety was assessed with an open-ended question: “Did you dislike anything about Seditol®?” The subjects were also instructed to contact the clinic in the event of any adverse events or side effects. Out of the 618 subjects who completed the study, 576 reported no dislikes (93.2%). Less than seven percent reported any dislikes: 4% groggy in the morning; 0.6% headaches (4 subjects); 0.3% kept awake at night (2 subjects); 0.8% bad taste (5 subjects); 0.5% unpleasant dreams (3 subjects). Light headed 0.2% (1 subject); nervous 0.2% (1 subject); feeling cold 0.2% (1 subject).
Next Pharmaceuticals, Inc. is a research and development company that markets its patented or patent-pending ingredients such as Relora®, Nexrutine®, Seditol® and Citri-Z® to food, beverage, and dietary supplement companies seeking differentiation and a marketing edge with their healthy living products. Media Contact: Connie St John, 415-454-2243, 415-302-7438 (mobile) or [email protected]