SAN DIEGO, CA September 4, 2013/PR Newswire – Two “super generic” drugs utilizing Aegis Therapeutics Intravail technology for treatment of migraine headaches and seizures are rapidly advancing through clinical trials under the FDA’s 505(b)2 pathway.
Rapid relief of certain medical conditions is dependent upon early establishment of therapeutic blood levels of drug. Examples include drugs for migraine headache, pain, seizures, emesis, spasticity, tremors (Parkinson’s disease), psychosis, and opioid overdose.
At present, rapid relief of migraine headaches is achievable only through injection of drugs called triptans, the most widely used being sumatriptan. The current oral or nasal spray sumatriptan products reach maximum blood levels in about 60 to 120 minutes thus delaying onset of relief. Human trials have shown Intravail® nasal spray formulations achieve therapeutic drug levels in approximately 2 to 3 minutes, 20 to 30 times faster than the currently marketed non-injectable sumatriptan products.
For seizures the only drug approved for treatment outside the hospital is diazepam rectal gel, a therapy that nearly all older children and adults decline to use. Lacking a viable option to deal with seizure emergencies at home, work, or in social settings, they end up with costly emergency room visits and hospital admissions, typically totally $3,000 or more per episode. The Intravail®-based nasal spray formulation of diazepam provides very high bioavailability (96% absolute bioavailability) with correspondingly low variability, providing a very attractive prospect of minimizing the impact and cost of seizure emergencies outside of the hospital setting.
A new Frost & Sullivan survey of more than 220 physicians and 650 patients titled “Drug Delivery Technology: End-User Preferences, Utilization and Perceptions” found that 54 percent of physicians treating migraines would prefer to switch to a drug using nasal administration. For physicians, principal motivations for selecting a drug delivery method are ensuring consistent patient compliance and effective outcomes.
Aegis’ Intravail® formulation technology is broadly applicable to a wide range of small molecule and biotherapeutic drugs to increase noninvasive bioavailability by the oral, nasal, buccal, and sublingual routes and to increase attainment of therapeutic drug levels in cases where speed or increased bioavailability is important to the clinical outcome.
To receive future press releases directly via email click here and enter your email address in the sign-up box at the bottom of the page. About Aegis Therapeutics Aegis Therapeutics LLC is a drug delivery technology company commercializing its patented drug delivery and drug formulation technologies through product-specific licenses. Our Intravail® drug delivery technology enables the non-invasive delivery of a broad range of protein, peptide and non-peptide drugs that can currently only be administered by injection, via the oral, buccal, and intranasal administration routes, and with high bioavailability. Our ProTek® excipients stabilize, prevent aggregation, and reduce unwanted immunogenicity of protein and peptide therapeutics while avoiding the oxidative damage caused by polysorbate surfactants.
For more information about Aegis, please visit: http://www.aegisthera.com.