INSYS Therapeutics Rises On Dose-Ranging Allergy Study Data
Zacks Investment Research | Jan 09, 2019 11:00PM ET
INSYS Therapeutics, Inc. (NASDAQ:INSY) announced positive results from its dose-finding pharmacokinetic ("PK") study —INS015-18-124—evaluating proprietary formulation of epinephrine nasal spray for treating anaphylaxis, an acute, life-threatening allergic reaction. Data from the study showed that the candidate has a similar PK profile with Mylan’s (NASDAQ:MYL) EpiPen as well as Par Pharmaceuticals’ Adrenalin (epinephrine injection).
With similar PK profile, the candidate provides a non-invasive delivery option to treat anaphylaxis as it is a nasal spray while EpiPen is an intramuscular injection.
Shares of the company were up 1.6% in after-hours trading following the news. However, INSYS’ shares have declined 41.4% in the past six months compared with the industry ’s decrease of 9.5%.
INSYS Therapeutics is currently evaluating the candidate in a phase II study.
The four-way crossover, dose-finding PK study is evaluating two doses of the epinephrine nasal sprayversus two reference drugs — 0.3mg dose of EpiPen and 0.5 mg dose of Adrenalin.
In a proof-of-concept PK study, data from which was announced in June 2018, the candidate has demonstrated rapid drug absorption through the nasal mucosa and bioavailability similar to EpiPen in nasal allergen.
Moreover, in August 2018, the FDA granted Fast Track designation to the candidate as a treatment for anaphylaxis.
INSYS Therapeutics is focused on the development, manufacture and commercialization of pharmaceutical cannabinoids and spray technology. The company has two marketed drugs in its portfolio – Subsys and Syndros. While Subsys, an opioid, is approved for managing cancer pain, Sundros, a cannabinoid, is available as a treatment foranorexia in AIDS patients, and nausea and vomiting caused by chemotherapy.
Amid declining sales of its top drug, Subsys and threat of generic competition for the same, as Teva Pharma (NYSE:TEVA) has filedan abbreviated new drug application, the successful development of epinephrine nasal spray will lead to significant market opportunity. However, completion of its development is years away.
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