FDA Approves RiVive (naloxone hydrochloride) Over-the-Counter Nasal Spray for the Emergency Remedy of Opioid Overdose


FDA Approves RiVive (naloxone hydrochloride) Over-the-Counter Nasal Spray for the Emergency Remedy of Opioid Overdose

Pittsburgh, Pennsylvania–(Newsfile Corp. – July 28, 2023) – Hurt Discount Therapeutics (HRT), Inc., a nonprofit pharmaceutical firm, introduced as we speak that FDA has authorised OTC RiVive™ (naloxone HCl nasal spray 3 mg) for the emergency remedy of opioid overdose. This vital milestone will assist forestall opioid overdose deaths by making free or low-cost over-the-counter (OTC) naloxone nasal spray obtainable to everybody in the US.

“We’re grateful that FDA granted RiVive approval so we will now obtain what most thought unattainable and no different firm has: broad supply of a lower-cost nasal naloxone product and not using a prescription to save lots of lives that would in any other case be misplaced to opioid overdose,” mentioned Michael Hufford, PhD, co-founder and chief govt officer of Hurt Discount Therapeutics, Inc.

No firm, entity, or particular person will revenue from gross sales of RiVive. As a nonprofit pharmaceutical firm, HRT is partaking extra funding companions to assist make its inexpensive opioid overdose remedy extra accessible. Companions can direct their monetary help to additional reducing the value of RiVive, making extra of it obtainable free to particular U.S. nonprofit hurt discount organizations, and/or serving to to extend manufacturing capability in order that extra lives will be saved.

Since 2017, greater than 290,000 individuals throughout the U.S. have died of an opioid overdose.1 HRT stands behind the precept articulated by the White Home and Workplace of Nationwide Drug Management Coverage Director Dr. Rahul Gupta that “nobody who wants overdose reversal drugs ought to lack entry due to prices or availability.”2

HRT started manufacturing RiVive at-risk to attenuate the standard lag between FDA approval and launch of a brand new product. In consequence, HRT anticipates that RiVive can be obtainable in early 2024 primarily to U.S. hurt discount organizations and state governments for prices decrease than different opioid antagonist nasal sprays. HRT is targeted on supplying RiVive to communities who want it most and can make at the least 200,000 doses (10% of projected preliminary annual product manufacturing) obtainable without spending a dime.

RiVive makes use of an easy-to-use customary unit dose system that can be utilized in an emergency state of affairs to reverse the life-threatening results of recognized or suspected opioid overdose. Every RiVive nasal spray gadget incorporates one dose of naloxone. It is going to be completely obtainable in twin packs containing two single-dose gadgets. It’s protected to maintain administering RiVive each two to a few minutes till the particular person wakes up.

RiVive is at the moment being produced beneath a business provide settlement with Catalent, a number one international contract growth and manufacturing group, at their facility in Morrisville, North Carolina.

About RiVive™
RiVive™ (naloxone HCl nasal spray 3 mg) is a novel over-the-counter intranasal formulation of naloxone (3.0 mg) delivered as an atomized spray (0.1 ml) that may save lives. It makes use of an easy-to-use customary unit dose system for single administration for the emergency remedy of opioid overdose and not using a prescription. RiVive produces a 3-fold greater systemic publicity with comparable early absorption to the reference naloxone product (0.4 mg delivered by way of intramuscular injection). Human elements validation work demonstrated that laypeople had been capable of administer RiVive in a simulated emergency overdose state of affairs. Warning: when utilizing this product, some individuals could expertise signs after they get up equivalent to shaking, sweating, nausea or feeling indignant. For extra data on Drug Info name toll free (888) 412.7454 or go to www.harmreductiontherapeutics.org.

About Naloxone
Naloxone is a protected and efficient FDA authorised opioid antagonist that has been used for many years to soundly and successfully reverse opioid overdoses.3

About Hurt Discount Therapeutics, Inc.
Hurt Discount Therapeutics (HRT), Inc. is a 501(c)(3) nonprofit pharmaceutical firm whose single mission is to forestall opioid overdose deaths by making free or low-cost over-the-counter naloxone obtainable to everybody. It’s the first nonprofit firm to attain FDA approval of a naloxone nasal spray. Based in 2017 in response to the extreme worth and entry limits to present naloxone merchandise, HRT brings collectively consultants in drug growth, hurt discount, substance dependence, public well being coverage, and over-the-counter switches of prescription prescribed drugs. For extra data, please go to www.harmreductiontherapeutics.org.

1Drug Overdose Dying Charges | Nationwide Institute on Drug Abuse (NIDA) (nih.gov)
2Assertion from ONDCP Director Dr. Rahul Gupta Relating to White Home Assembly on Rising Entry and Affordability of FDA-Accepted Overdose Reversal Drugs | ONDCP | The White Home.
For instance: Avetian, et al. (2018) DOI : 10.1080/03007995.2017.1334637 ; Bennett, et al. (2018) DOI : 10.1080/02791072.2018.1430409; Campbell (2020). ISBN: 978-0262043663; https://remedyallianceftp.org/pages/historical past.

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