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DUBLIN, IRELAND--(Marketwired - November 19, 2015) - Adapt Pharma Limited (www.adaptpharma.com) appear today that the U.S. Food and Drug Administering (FDA) has accustomed NARCAN® (naloxone hydrochloride) Nasal Aerosol for the emergency analysis of accepted or doubtable opioid overdose. For multimedia content, amuse appointment http://inr.synapticdigital.com/adaptpharma/NARCAN/.
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For added than 40 years, naloxone has been trusted by healthcare providers for abandoning the furnishings of opioid overdose, but until today, it was FDA accustomed alone as an injection.
NARCAN Nasal Spray, a ready-to-use, needle-free device, delivers a 4 mg dosage of naloxone in a distinct 0.1 ml nasal spray. NARCAN Nasal Aerosol requires no accumulation or conference above-mentioned to use.
Adapt Pharma is committed to affordable and cellophane appraisement of NARCAN Nasal Spray. Accumulation purchasers, such as law enforcement, blaze fighters, aboriginal responders, departments of health, bounded academy districts, colleges and universities, and community-based organizations that adjustment anon from Adapt Pharma, are acceptable for a discounted Public Interest Price of $37.50 per 4mg NARCAN Nasal Aerosol accessory ($75 for a carton absolute 2 accessories of NARCAN Nasal Aerosol 4mg).(1)
We are captivated to accept accomplished acceding with the Clinton Bloom Matters Initiative, an activity of the Clinton Foundation, our aboriginal accomplice in establishing this discounted Public Interest Price approach. "The Clinton Bloom Matters Activity is committed to efforts to abate opioid balance deaths, including by authoritative naloxone added broadly available," said Rain Henderson, CEO of the Clinton Bloom Matters Initiative, an activity of the Clinton Foundation. "We accept that the affiliation and appraisement acceding with Adapt will abetment us in allowance organizations beyond the United States to save lives by authoritative naloxone added affordable and attainable for those who charge it most."
We apprehend to advertise added partnerships soon. To apprentice more, accumulation purchasers may alarm 844-4-NARCAN (844-462-7226) or email customerservice@adaptpharma.com. For individuals with bloom allowance coverage, NARCAN Nasal Aerosol is accepted to accept ample advantage with affordable co-pays.
NARCAN Nasal Aerosol can be administered in an emergency by ancestors members, caregivers or others to about-face the furnishings of opioid balance until advice arrives. An opioid balance may account academician accident or death, so NARCAN Nasal Aerosol should be administered as bound as accessible if a accommodating is above and an opioid balance is suspected, alike aback in doubt.
In the United States, opioid balance accompanying deaths are growing and claimed about 24,500 lives in 2013, or an boilerplate of one activity every 21 minutes.(2) The majority of those deaths complex decree opioids(3) and happened in people's homes.(4)
In response, drive to admission admission to naloxone is building. In October, President Obama included a alarm to accomplish naloxone added readily attainable as allotment of a above activity to abode the nation's opioid epidemic.(5) Above medical groups, including the American Medical Association and American Academy of Ancestors Physicians, accept additionally alleged for added admission to naloxone.(6)
"Opioid balance is amenable for the deaths of bags of Americans in communities throughout the country, abrogation a aisle of confusion for accompany and families," said Seamus Mulligan, Chairman and CEO of Adapt Pharma. "NARCAN Nasal Aerosol a ready-to-use, needle-free device, delivers a 4 mg dosage of naloxone in a distinct 0.1 ml nasal spray. This new accessory makes naloxone readily attainable for emergency use by a friend, ancestors affiliate or caregiver, as able-bodied as alms an another analysis advantage for aboriginal responders and healthcare providers. It gives new achievement to those anxious about the potentially baleful furnishings of opioid overdose."
Anyone who uses decree opioids for the connected appellation administering of abiding pain, or those who booty heroin, are potentially at accident of experiencing a life-threatening or baleful opioid balance area breath and affection exhausted apathetic or stop.(7) Decree opioids accommodate morphine, codeine, methadone, oxycodone (e.g. OxyContin®, Percocet®), hydrocodone (e.g. Vicodin®, Lortab®), fentanyl (e.g. Duragesic®, Fentora®), hydromorphone (e.g. Dilaudid®, Exalgo®), oxymorphone (Opana® ER), and buprenorphine (Subutex®, Suboxone®). Illicit opioids accommodate heroin and added heroin/fentanyl mixes.
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"Overdoses can potentially activity anytime and anywhere opioids are actuality used. That is why accretion admission to naloxone, which can rapidly about-face an overdose, is actuality encouraged by several able organizations," said Dr. Anita Gupta, a board-certified anesthesiologist, pharmacist and affliction specialist. "By authoritative naloxone attainable and accessible to use for anyone demography an opioid, as able-bodied as their ancestors associates and admired ones, we may be able to abatement causeless opioid balance deaths."
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"After my son's passing, I fabricated a vow to him that I was activity to save a activity in his name," said David Humes, who absent his 24-year-old son, Gregory, to an adventitious heroin balance in May 2012. "Since then, I accept been a amorous apostle for the broader administering and use of naloxone. I accept the approval of added opioid balance analysis options, like NARCAN Nasal Spray, may abundantly admission admission to this potentially lifesaving medication. Accretion admission to naloxone became my aisle against accomplishing my vow to my son and allowance to anticipate a agnate affliction for added parents."
Adapt Pharma collaborated with the National Institutes on Drug Abuse (NIDA) on the development of NARCAN Nasal Spray, which accustomed Fast Track Designation and a Priority Review by the FDA.
Adapt Pharma originally accountant the activity from Lightlake Therapeutics, Inc. It is attainable in a carton absolute two abscess packages, anniversary with a distinct NARCAN Nasal Aerosol absolute a distinct 4 mg dosage of naloxone hydrochloride intranasal spray.
ABOUT NARCAN NASAL SPRAY
NARCAN Nasal Aerosol is adumbrated for the emergency analysis of accepted or doubtable opioid overdose, as embodied by respiratory and/or axial afraid arrangement depression.
NARCAN Nasal Aerosol is advised for actual administering as emergency analysis in settings area opioids may be present.
NARCAN Nasal Aerosol is not a acting for emergency medical care. Always seek emergency medical abetment in the accident of a suspected, potentially life-threatening opioid emergency afterwards administering of the aboriginal dosage of NARCAN nasal spray.
If the adapted acknowledgment is not acquired afterwards 2 or 3 minutes, administrate an added dosage of NARCAN Nasal Aerosol application a new NARCAN Nasal Spray. If the accommodating responds to NARCAN Nasal Aerosol and relapses aback into respiratory abasement afore emergency abetment arrives, administrate an added dosage and abide surveillance of the patient. If there is still no acknowledgment and added doses are available, administrate added doses of NARCAN Nasal Aerosol every 2 to 3 account application a new NARCAN Nasal Aerosol with anniversary dosage until emergency medical abetment arrives. Added admiring and/or resuscitative measures may be accessible while apprehension emergency medical assistance.
Please see Indications and Important Assurance Advice below. Abounding prescribing advice for NARCAN Nasal Spray, including important assurance information, is additionally attainable at www.NarcanNasalSpray.com.
AVAILABILITY OF NARCAN NASAL SPRAY
Once launched, in aboriginal 2016, we apprehend NARCAN Nasal Aerosol will be attainable at retail pharmacies.
Qualifying accumulation purchasers may antecedent NARCAN Nasal Aerosol anon from wholesalers and distributors. To abode a pre-order anon or for abetment in sourcing NARCAN Nasal Aerosol amuse acquaintance Adapt Pharma's committed Customer Service Team at 844-4-NARCAN (844-462-7226) or email customerservice@adaptpharma.com
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INDICATIONS
NARCAN (naloxone hydrochloride) Nasal Aerosol is an opioid adversary adumbrated for the emergency analysis of accepted or doubtable opioid overdose, as embodied by respiratory and/or axial afraid arrangement depression.
NARCAN Nasal Aerosol is advised for actual administering as emergency analysis in settings area opioids may be present.
NARCAN Nasal Aerosol is not a acting for emergency medical care.
IMPORTANT SAFETY INFORMATION
NARCAN Nasal Aerosol is contraindicated in patients accepted to be astute to naloxone hydrochloride.
Seek emergency medical abetment anon afterwards antecedent use, befitting the accommodating beneath connected surveillance.
Risk of Recurrent Respiratory and CNS Depression: Due to the continuance of activity of naloxone about to the opioid, accumulate the accommodating beneath connected surveillance and administrate echo doses of naloxone application a new nasal aerosol with anniversary dose, as necessary, while apprehension emergency medical assistance.
Risk of Limited Efficacy with Fractional Agonists or Alloyed Agonists/Antagonists: Changeabout of respiratory abasement acquired by fractional agonists or alloyed agonists/antagonists, such as buprenorphine and pentazocine, may be incomplete. Larger or echo doses may be required.
Precipitation of Severe Opioid Withdrawal: Use in patients who are opioid abased may accelerate opioid abandonment and astute abandonment syndrome. In neonates, opioid abandonment may be life-threatening if not accustomed and appropriately treated. Monitor for development of opioid withdrawal.
Risk of Cardiovascular (CV) Effects: Abrupt postoperative changeabout of opioid abasement may aftereffect in adverse CV effects. These contest accept primarily occurred in patients who had above-mentioned CV disorders or accustomed added drugs that may accept agnate adverse CV effects. Monitor these patients carefully in an adapted healthcare ambience afterwards use of naloxone hydrochloride.
The afterward adverse reactions were empiric in a NARCAN Nasal Aerosol analytic study: added claret pressure, musculoskeletal pain, headache, nasal dryness, nasal edema, nasal congestion, and nasal inflammation.
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See Instructions for Use and abounding prescribing advice in the use of this product.
To address SUSPECTED ADVERSE REACTIONS, acquaintance Adapt Pharma, Inc. at 1-844-4NARCAN (1-844-462-7226) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
ABOUT ADAPT PHARMA
Adapt Pharma Limited is a privately-held biologic aggregation committed to absolutely impacting the lives of patients. Adapt Pharma's action is to identify, evaluate, selectively access and enhance the amount of backward date development, and FDA approved, biologic products. Adapt Pharma's aggregation address is in Dublin, Ireland and its U.S. address is in Radnor, Pennsylvania. For added information, amuse appointment www.adaptpharma.com.
(1) Admission to Public Interest Price is belted to condoning entities and accountable to agreement and conditions.
(2) Centers for Disease Control and Prevention: NCHS Data Brief Number 190, March 2015 http://www.cdc.gov/nchs/data/databriefs/db190.htm#ref2
(3) Ibid
(4) CDC Wonder Database Multiple Account of Afterlife MCD - ICD-10 Codes: T40.1 (Heroin), T40.2 (Other opioids), T40.3 (Methadone), T40.4 (Other constructed narcotics) 2013
(5) The White House Office of the Press Secretary. FACT SHEET: Obama Administering Announces Public and Private Sector Efforts to Abode Decree Drug Abuse and Heroin Use. 2015. Attainable at: https://www.whitehouse.gov/the-press-office/2015/10/21/fact-sheet-obama-administration-announces-public-and-private-sector
(6) American Medical Association. The American Medical Association Task Force to Abate Decree Opioid Abuse. 2015. Attainable at: http://www.ama-assn.org/ama/pub/advocacy/topics/preventing-opioid-abuse/opioid-abuse-task-force.page
(7) Substance Abuse and Mental Bloom Services Administration. SAMHSA Opioid Balance Prevention Toolkit. HHS Publication No. (SMA) 14-4742. Rockville, MD: Substance Abuse and Mental Bloom Services Administration, 2014.
©2015 ADAPT Pharma Allotment #ADPT-14-15
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ADAPT Pharma
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