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| == Design == | == Design == | ||
| The devices contain a fixed dose of epinephrine and a spring-loaded needle that exits the tip or edge of the device and penetrates the recipient's skin, to deliver the medication via ] |
The devices contain a fixed dose of epinephrine and a spring-loaded needle that exits the tip or edge of the device and penetrates the recipient's skin, to deliver the medication via ].<ref name=Dinaker2012rev/> | ||
| ==History== | ==History== | ||
Revision as of 17:52, 25 August 2016
An epinephrine autoinjector is a medical device for injecting a measured dose or doses of epinephrine (adrenaline) by means of autoinjector technology. It is most often used for the treatment of anaphylaxis. One autoinjector, the EpiPen, is derived from the Mark I NAAK ComboPen, which was developed for the U.S. military for treating exposure to nerve agents in the course of chemical warfare. As of 2012 in the US, trademark names for epinephrine autoinjector devices included Adrenaclick, Anapen, EpiPen, Jext, and TwinJect.
Medical uses
Epinephrine auto-injectors are hand-held devices carried by those who have severe allergies; the epinephrine delivered by the device is an emergency treatment for anaphylactic reaction.
Their advantage over use of a syringe is safety; the dose is fixed, the user does not have to handle an exposed needle, and intramuscular injection avoids the risk of injection into a vein, which can be fatal, causing ventricular tachycardia, in which the heart beats uncontrollably and is not able to pump blood adequately.
Units that have exceeded their expiration date can still be used in an emergency if an unexpired unit is unavailable and the solution is neither discoloured nor contains precipitates.
Design
The devices contain a fixed dose of epinephrine and a spring-loaded needle that exits the tip or edge of the device and penetrates the recipient's skin, to deliver the medication via intramuscular injection.
History
The first modern epinephrine auto-injector, the EpiPen, was invented in the mid-1970s at Survival Technology in Bethesda, Maryland by Sheldon Kaplan.
In 2003 another epinephrine autoinjector, Adrenaclick, was approved for marketing. It was discontinued but re-introduced to the market in 2013.
In 2005 an epinephrine auto-injector version that contained two individual doses, Twinject, was launched. The company that produced Twinject autoinjectors, Shionogi, announced that it was discontinuing Twinject effective March 30, 2012.
In 2010, European regulators approved a new epinephrine auto-injector made by ALK and sold under the brand name Jext. The product was launched in the European Union in September 2011.
On August 13, 2012, the U.S. Food and Drug Administration (FDA) approved a new version of epinephrine auto-injector developed by Intelliject equipped with a sound chip to provide electronic voice instructions to guide the user in the proper use of the device. (The device is made and marketed by Sanofi who licensed the North American commercialization rights to it from Richmond-based kaléo, formerly known as Intelliject.) It is called Auvi-Q in the US (the same name initially used by Intelliject), and Allerject in Canada.
In 2013 the "School Access to Emergency Epinephrine Act" became law after passing Congress with broad and bipartisan support; it protected anyone from liability if they administered epinephrine to a child in a school (previously, only trained professionals or the affected person were allowed to administer the drug, and were open to liability), and it provided some financial incentives for schools that didn’t already stock epinephrine autoinjector to start stocking them.
In October 2015 the epinephrine auto-injection devices Auvi-Q and in Canada as Allerject, were voluntarily recalled by Sanofi. The reason stated by Sanofi was that the products have been found to potentially have inaccurate dosage delivery, which may include failure to deliver drug.
Society and culture
Cost
Mylan acquired the EpiPen line of epinephrine autoinjector devices from Merck KGaA as part of their 2007 deal. The devices deliver about $1 worth of drug. At that time annual sales were around $200M. Heather Bresch, Mylan's CEO, saw an opportunity to increase sales in the US through marketing and advocacy, and the company launched a marketing campaign to increase awareness of the dangers of anaphylaxis for people with severe allergies that made "EpiPen" the equivalent of "Kleenex"; the company also successfully lobbied the FDA to broaden the label to include risk of anaphylaxis and in parallel, successfully lobbied Congress to generate legislation making EpiPens available in public places like defibrillators are, and hired the same people that Medtronic had worked with on defibrillator legislation to do so. Mylan's efforts to gain market dominance were aided when Sanofi's competing product was recalled in November 2015 and further when Teva's generic competitor was rejected by the FDA in March 2016. By the first half of 2015, Mylan had an 85% market share of such devices in the US and in that year sales reached around $1.5B and accounted for 40% of Mylan's profit. Those profits were also due in part to Mylan's continually raising the price of EpiPens starting in 2009; in 2007 the wholesale price of two EpiPens was about $100, the price was about the same in 2009, by July 2013 the price about $265, in May 2015 it was around $461, and in May 2016 the price rose again to around $609, around a 500% jump from the price in 2009. The last price increase sparked widespread outrage, including criticism from Martin Shkreli, "poster boy for grasping pharma greed," letters from two Senators and initiation of Congressional investigations.
As of August 2016 Adrenaclick cost $142.
References
- ^ Smetana, Kevin (September 24, 2009). "EpiPen inventor helped millions and died in obscurity". St. Petersburg Times. Archived from the original on February 1, 2013. Retrieved 2010-07-07.
{{cite web}}: Unknown parameter|deadurl=ignored (|url-status=suggested) (help) - ^ Dinakar, C (December 2012). "Anaphylaxis in children: current understanding and key issues in diagnosis and treatment". Current allergy and asthma reports. 12 (6): 641–9. PMID 22815131.
- Simons, FE; Gu, X; Simons, KJ (May 2000). "Outdated EpiPen and EpiPen Jr autoinjectors: past their prime?". The Journal of allergy and clinical immunology. 105 (5): 1025–30. doi:10.1067/mai.2000.106042. PMID 10808186.
- FDA Adrenaclick approval history Page accessed August 25, 2016
- "Amedra Pharmaceuticals re-launches single-dose epinephrine auto-injector". Adrenaclick. June 15, 2013.
- Verus Pharmaceuticals Announces U.S. Launch of Twinject for Anaphylaxis
- "ALK media release (07 October 2010)". Retrieved 2014-04-08.
- "ALK media release (13 October 2010)". Retrieved 2014-04-08.
- "ALK media release (06 September 2011)". Retrieved 2014-04-08.
- "Kaléo Pharma - Intelliject, Inc. Receives FDA Approval for Auvi-Q™ (epinephrine injection, USP)".
- ^ http://en.sanofi.com/Images/30999_20120813_EAI_FDA_APPROVAL_en.pdf
- "Auvi-Q Fact Sheet" (PDF). Retrieved 18 August 2012.
- "Auvi-Q auto injector being recalled". Richmond Times-Dispatch.
- http://www.allerject.ca/en/epinephrine-autoinjector Allerject
- Novak, Matt (August 23, 2016). "How Congress, the FDA, and Sarah Jessica Parker Helped EpiPen Become a $1 Billion Business". Gizmodo.
- "Allerject epinephrine auto-injectors recalled by drugmaker Sanofi". 30 October 2015.
- http://www.allerject.ca/Common/docs/en/Sanofi-Canada-Issues-Voluntary-Recall-of-Allerject.pdf
- "Auvi-Q® (epinephrine injection, USP)". Auvi-Q.
- "UPDATED: Sanofi US Issues Voluntary Nationwide Recall of All Auvi-Q® Due to Potential Inaccurate Dosage Delivery".
- ^ Tara Parker-Pope and Rachel Rabkin Peachman for the New York Times. Aug 22, 2016 EpiPen Price Rise Sparks Concern for Allergy Sufferers
- ^ Cynthia Koons and Robert Langreth for Bloomberg Businessweek. September 23, 2015 How Marketing Turned the EpiPen Into a Billion-Dollar Business
- Carly Helfand for FiercePharma Mar 1, 2016 FDA swats down Teva's EpiPen copy, putting Mylan in cruise control
- ^ Emily Willingham for Forbes. Aug 21, 2016 Why Did Mylan Hike EpiPen Prices 400%? Because They Could
- Bartolotta, Devin (18 August 2016). "Cost Jumps Nearly 500-Percent For Life-Saving EpiPens". CBS Baltimore. Retrieved 19 August 2016.
- Emma Court for MarketWatch. Aug 18, 2016 Mylan’s EpiPen price increases are Valeant-like in size, Shkreli-like in approach
- Goldberg, Kenny. "People With Food Allergies Say Life-Saving Drug Too Expensive". KPBS Public Media. Retrieved 8 June 2016.
- Ginger Skinner (August 11, 2016). "Can You Get A Cheaper EpiPen?".
- Lack of competition leads to EpiPen pricing woes, Adam Rubenfire, Modern Healthcare, March 28, 2016
- BMJ Clinical Review of Epinephrine Administration. Accessed on March 19, 2007.
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