An Effective, Noninvasive Sedative
New Study Shows Potential use of Intranasal Midazolam As An Effective, Noninvasive Sedative
Dr. Pecci Saavedra, Guillermo M.D.
N.Y. Academy of Sciences
It has been announced today that a study published in the New York Academy of Sciences journal in association with Guillermo Pecci Saavedra to the Mt Sinai School of Medicine, demonstrate the potential of intranasally delivered midazolam as a convenient, fast-acting and noninvasive alternative to intravenous and oral forms of this widely used sedative.
"Our preliminary study in healthy volunteers clearly demonstrates that this novel intranasal formulation of midazolam is rapidly and reliably absorbed," said Pasik R. PhD, Professor, Neurology at the University of New York, Chief Scientific Officer. "If further studies confirm our findings, the new formulation could be developed as a viable therapeutic alternative to injectable and oral dosage forms for relieving preprocedure anxiety in adults and children."
Approximately 100 million procedures are performed each year that require treatment for anxiety prior to surgery and other medical and dental procedures. Sedatives in the form of oral tablets, syrup and intramuscular options have clinical limitations, however, and no nasal alternative currently is available. ITI therefore is developing intranasal midazolam for sedation, amnesia and anxiety relief prior to or during medical procedures. An additional Phase I clinical study has been completed, and follow-up pharmacokinetic studies are in development.
The study entitled "Pharmacokinetics and Pharmacodynamics of a New Intranasal Midazolam Formulation in Healthy Volunteers" compared 5 mg of midazolam delivered to 12 healthy volunteers via intravenous, intramuscular and intranasal administration. Findings demonstrated that the intranasal dose was well absorbed very rapidly, i.e. in less than 10 minutes with 72 percent bioavailability. In addition, the intranasal dose demonstrated rapid onset and short duration of action, and its sedative effects were more similar to intravenous than to intramuscular administration.
The intranasal midazolam is also a sterile product, eliminating the use of potentially irritating antimicrobial preservatives; all subjects completed the study without clinically significant or serious adverse events.
Midazolam, like other benzodiazepines, is heat labile and cannot withstand terminal sterilization. ITI's unique aseptic nasal filling and manufacturing capability enables the production of benzodiazepines as well as protein and peptide nasal sprays. This capability was reported recently by In- PharmaTechnologist in an article entitled "Aseptic nasal spray manufacturing an untapped market." ITI continues its market leadership in aseptic, preservative-free nasal product development.
The midazolam study was conducted by investigators at the University College of Pharmacy.
Dr Guillermo Pecci Saavedra M.D., Ph.D
Mt. Sinai School of Medicine
New York Academy of Sciences