Insys Therapuetics Issues A Statement
Insys has issued a contention regarding their Subsys business...
Insys Therapeutics Issues Clarifying Statement
PHOENIX, AZ--(Marketwired - May 12, 2014) - Insys Therapeutics, Inc. (NASDAQ: INSY) today issued a clarifying contention regarding its Subsys® (fentanyl sublingual spray) product.
Insys takes patient security real seriously together with nosotros are committed to working alongside physicians to help ensure the proper prescribing together with usage of our products.
In price of our business, nosotros cause got continually expanded our commercial arrangement since launch due to the success of Subsys inwards treating pause through cancer hurting inwards opioid tolerant cancer patients who are xviii years or older. As such, nosotros cause got expanded our prescriber base of operations together with for 2014 year-to-date, no unmarried physician has written to a greater extent than than 5% of total Subsys prescriptions.
Based on recent activity, nosotros experience it is appropriate to summarize together with address to a greater extent than or less of the of import items regarding Subsys. Subsys is governed past times the Transmucosal Immediate Release Fentanyl ("TIRF") Risk Evaluation together with Mitigation Strategy ("REMS") Access program, which was approved together with launched past times the FDA inwards March 2012. lnsys began commercializing Subsys on March 26, 2012 afterward the implementation of this TIRF-REMS program.
This TIRF-REMS programme is designed to ensure informed risk-benefit decisions earlier initiating handling together with appropriate usage of TIRF medicines. The purpose of the TIRF-REMS programme is to mitigate the guide chances of misuse, abuse, addiction, overdose together with serious complications due to medication errors alongside the usage of TIRF medicines. Subsys tin strength out solely endure prescribed afterward physicians cause got undergone grooming on the risks together with benefits of such products together with products tin strength out solely endure dispensed via pharmacies who are REMS enrolled. Additionally, all patients together with physicians are required to sign a prescriber patient understanding cast equally role of this process. Insys continues to back upward the TIRF-REMS programme that was co-developed alongside other player companies. More data regarding the TIRF-REMS programme tin strength out endure constitute at www.tirfremsaccess.com.
Insys does non sell straight to physicians. lnsys solely sells Subsys through DEA approved wholesalers who monitor together with rails prescribing activity for this TIRF course of pedagogy of drugs together with all opioids. Insys remains committed to our compliance programme together with protocols inwards house that are designed to ensure our sales together with marketing practices comply alongside applicable laws.
About Insys Therapeutics, Inc.
Insys Therapeutics is a specialty pharmaceutical companionship that develops together with commercializes innovative products for supportive help of cancer together with hurting patients. Using its proprietary sublingual spray applied scientific discipline together with its capability to develop pharmaceutical cannabinoids, the companionship addresses the clinical shortcomings of existing commercial products. The companionship currently markets 2 products, Subsys, which is sublingual Fentanyl spray for pause through cancer pain, together with a generic version of Dronabinol (THC) capsules. The companionship plans to file a New Drug Application (NDA) for an oral liquid formulation of Dronabinol inwards the minute one-half of 2014 together with believes it is a clinically superior production to electrical current Dronabinol capsules. The companionship is developing a pipeline of sublingual sprays, too equally pharmaceutical CBD.
Forward-Looking Statements
This press unloosen contains forward-looking statements including the statements related to plans to file a New Drug Application (NDA) for an oral liquid formulation of Dronabinol inwards the minute one-half of 2014, the Company's belief that this oral liquid formulation of Dronabinol is a clinically superior production to electrical current Dronabinol capsules together with the Company's contention consider a pipeline of sublingual sprays, too equally pharmaceutical CBD. These forward-looking statements are based on management's expectations together with assumptions equally of the engagement of this press release, together with actual results may differ materially from those inwards these forward-looking statements equally a effect of diverse factors, many of which are beyond our control. For a description of these risks facing the Company, delight come across the guide chances factors described inwards our filings alongside the U.S.A. Securities together with Exchange Commission, including those factors discussed nether the caption "Risk Factors" inwards our Annual Report on Form 10-K for the yr ended Dec 31, 2013 together with whatever subsequent updates that may laissez passer on inwards our Quarterly Reports on Form 10-Q. Forward-looking statements verbalize solely equally of the engagement of this press unloosen together with nosotros undertake no obligation to update or revise these statements, except equally may endure required past times law.
Contact:
Contact:
Lisa M. Wilson
President
In-Site Communications, Inc.
T: 212-452-2793
E: lwilson@insitecony.com
I volition restrain myself to 2 things.
(a). They signal out correctly they produce non sell straight to doctors. No drug companionship does. Instead they educate doctors almost the drug together with hopefully the doctors write a script which is collected past times the patients. This whole department elides the number of how the incentive marketing system grates against the laws regarding off-label marketing together with the like. It is the interaction betwixt the incentive programme together with alleged off-label prescriptions past times the indicted Dr. that thing here.
(b). They detect that Subsys tin strength out solely endure prescribed nether restrictive conditions... "Subsys tin strength out solely endure prescribed afterward physicians cause got undergone grooming on the risks together with benefits of such products together with products tin strength out solely endure dispensed via pharmacies who are REMS enrolled. Additionally, all patients together with physicians are required to sign a prescriber patient understanding cast equally role of this process. Insys continues to back upward the TIRF-REMS programme that was co-developed alongside other player companies."
This does non check the alleged conduct of the Dr. inwards query who was allegedly prescribing narcotics for something that looked similar carpels tunnel syndrome.
Just saying.
John
Insys Therapeutics Issues Clarifying Statement
PHOENIX, AZ--(Marketwired - May 12, 2014) - Insys Therapeutics, Inc. (NASDAQ: INSY) today issued a clarifying contention regarding its Subsys® (fentanyl sublingual spray) product.
Insys takes patient security real seriously together with nosotros are committed to working alongside physicians to help ensure the proper prescribing together with usage of our products.
In price of our business, nosotros cause got continually expanded our commercial arrangement since launch due to the success of Subsys inwards treating pause through cancer hurting inwards opioid tolerant cancer patients who are xviii years or older. As such, nosotros cause got expanded our prescriber base of operations together with for 2014 year-to-date, no unmarried physician has written to a greater extent than than 5% of total Subsys prescriptions.
Based on recent activity, nosotros experience it is appropriate to summarize together with address to a greater extent than or less of the of import items regarding Subsys. Subsys is governed past times the Transmucosal Immediate Release Fentanyl ("TIRF") Risk Evaluation together with Mitigation Strategy ("REMS") Access program, which was approved together with launched past times the FDA inwards March 2012. lnsys began commercializing Subsys on March 26, 2012 afterward the implementation of this TIRF-REMS program.
This TIRF-REMS programme is designed to ensure informed risk-benefit decisions earlier initiating handling together with appropriate usage of TIRF medicines. The purpose of the TIRF-REMS programme is to mitigate the guide chances of misuse, abuse, addiction, overdose together with serious complications due to medication errors alongside the usage of TIRF medicines. Subsys tin strength out solely endure prescribed afterward physicians cause got undergone grooming on the risks together with benefits of such products together with products tin strength out solely endure dispensed via pharmacies who are REMS enrolled. Additionally, all patients together with physicians are required to sign a prescriber patient understanding cast equally role of this process. Insys continues to back upward the TIRF-REMS programme that was co-developed alongside other player companies. More data regarding the TIRF-REMS programme tin strength out endure constitute at www.tirfremsaccess.com.
Insys does non sell straight to physicians. lnsys solely sells Subsys through DEA approved wholesalers who monitor together with rails prescribing activity for this TIRF course of pedagogy of drugs together with all opioids. Insys remains committed to our compliance programme together with protocols inwards house that are designed to ensure our sales together with marketing practices comply alongside applicable laws.
About Insys Therapeutics, Inc.
Insys Therapeutics is a specialty pharmaceutical companionship that develops together with commercializes innovative products for supportive help of cancer together with hurting patients. Using its proprietary sublingual spray applied scientific discipline together with its capability to develop pharmaceutical cannabinoids, the companionship addresses the clinical shortcomings of existing commercial products. The companionship currently markets 2 products, Subsys, which is sublingual Fentanyl spray for pause through cancer pain, together with a generic version of Dronabinol (THC) capsules. The companionship plans to file a New Drug Application (NDA) for an oral liquid formulation of Dronabinol inwards the minute one-half of 2014 together with believes it is a clinically superior production to electrical current Dronabinol capsules. The companionship is developing a pipeline of sublingual sprays, too equally pharmaceutical CBD.
Forward-Looking Statements
This press unloosen contains forward-looking statements including the statements related to plans to file a New Drug Application (NDA) for an oral liquid formulation of Dronabinol inwards the minute one-half of 2014, the Company's belief that this oral liquid formulation of Dronabinol is a clinically superior production to electrical current Dronabinol capsules together with the Company's contention consider a pipeline of sublingual sprays, too equally pharmaceutical CBD. These forward-looking statements are based on management's expectations together with assumptions equally of the engagement of this press release, together with actual results may differ materially from those inwards these forward-looking statements equally a effect of diverse factors, many of which are beyond our control. For a description of these risks facing the Company, delight come across the guide chances factors described inwards our filings alongside the U.S.A. Securities together with Exchange Commission, including those factors discussed nether the caption "Risk Factors" inwards our Annual Report on Form 10-K for the yr ended Dec 31, 2013 together with whatever subsequent updates that may laissez passer on inwards our Quarterly Reports on Form 10-Q. Forward-looking statements verbalize solely equally of the engagement of this press unloosen together with nosotros undertake no obligation to update or revise these statements, except equally may endure required past times law.
Contact:
Contact:
Lisa M. Wilson
President
In-Site Communications, Inc.
T: 212-452-2793
E: lwilson@insitecony.com
I volition restrain myself to 2 things.
(a). They signal out correctly they produce non sell straight to doctors. No drug companionship does. Instead they educate doctors almost the drug together with hopefully the doctors write a script which is collected past times the patients. This whole department elides the number of how the incentive marketing system grates against the laws regarding off-label marketing together with the like. It is the interaction betwixt the incentive programme together with alleged off-label prescriptions past times the indicted Dr. that thing here.
(b). They detect that Subsys tin strength out solely endure prescribed nether restrictive conditions... "Subsys tin strength out solely endure prescribed afterward physicians cause got undergone grooming on the risks together with benefits of such products together with products tin strength out solely endure dispensed via pharmacies who are REMS enrolled. Additionally, all patients together with physicians are required to sign a prescriber patient understanding cast equally role of this process. Insys continues to back upward the TIRF-REMS programme that was co-developed alongside other player companies."
This does non check the alleged conduct of the Dr. inwards query who was allegedly prescribing narcotics for something that looked similar carpels tunnel syndrome.
Just saying.
John
No comments