Insys Completes Study on Dronabinol Oral Solution - Analyst Blog

By
A A A

Insys Therapeutics, Inc . ( INSY ) announced that it has successfully completed a human abuse study on dronabinol oral solution, a liquid formulation of the synthetic cannabinoid dronabinol.

Insys conducted the human abuse study as per the requirements of the U.S. Drug Enforcement Agency for classification purposes.

Insys completed the clinical study as required for the New Drug Application (NDA) filing during the third quarter of 2013. Earlier, Insys completed a pre-NDA meeting with the FDA and a pivotal bioequivalence study for the dronabinol oral solution in 2012.

Insys now expects to file the NDA in the third quarter of 2014.

We remind investors that Insys received FDA approval for dronabinol capsules, a generic equivalent of Marinol, an approved second-line treatment for chemotherapy induced nausea and vomiting (CINV) and anorexia associated with weight loss in AIDS patients in Aug 2011.

The oral solution is expected to lead to faster onset of action along with better dosage flexibility as compared to capsules.

Insys has an exclusive supply and distribution agreement with Mylan, Inc. ( MYL ) whereby Mylan holds the right to distribute dronabinol capsules in the U.S.

Last week, Insys announced that the FDA has granted orphan drug status to its epilepsy candidate, pharmaceutical cannabidiol, for treating Dravet syndrome, a rare form of intractable epilepsy that commences in infancy.

Insys carries a Zacks Rank #4 (Sell). Some better-ranked stocks in the broader healthcare sector include Allergan ( AGN ) and AbbVie ( ABBV ). Both stocks carry a Zacks Rank #2 (Buy).


Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report

INSYS THERAP (INSY): Free Stock Analysis Report

ALLERGAN INC (AGN): Free Stock Analysis Report


MYLAN INC (MYL): Free Stock Analysis Report

ABBVIE INC (ABBV): Free Stock Analysis Report

To read this article on Zacks.com click here.

Zacks Investment Research



The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of The NASDAQ OMX Group, Inc.




This article appears in: Investing , Business , Stocks

Referenced Stocks: INSY , AGN , MYL , ABBV

Zacks.com

Zacks.com

More from Zacks.com:

Related Videos

Visualizing Healthcare MG
Visualizing Healthcare MG           
Power on/Power Off IPC
Power on/Power Off IPC              
Spot the Dropout RRC
Spot the Dropout RRC                
Power on/Power Off
Power on/Power Off                  

Stocks

Referenced

Most Active by Volume

105,858,039
  • $10.50 ▲ 3.04%
105,433,684
  • $29.22 ▲ 4.62%
72,716,790
  • $16.36 ▼ 0.49%
51,381,067
  • $113.29 ▲ 0.33%
47,443,661
  • $2.39 ▲ 4.82%
45,387,229
  • $5.78 ▲ 0.87%
45,001,566
  • $105.62 ▼ 0.02%
42,379,286
  • $28.42 ▲ 2.53%
As of 8/28/2015, 04:15 PM

Find a Credit Card

Select a credit card product by:
Select an offer:
Search
Data Provided by BankRate.com