Harm Reduction Therapeutics

What Harm Reduction Therapeutics does

Harm Reduction Therapeutics (HRT) is a 501(c)(3) nonprofit pharmaceutical company founded in 2017 and headquartered in Bethesda, Maryland. It operates with a small, largely virtual team of fewer than 50 staff, focusing on a single mission: expanding access to low-cost opioid overdose reversal medication. Its sole commercial product is RiVive, an over-the-counter 3 mg naloxone hydrochloride nasal spray FDA-approved in July 2023 for emergency treatment of known or suspected opioid overdoses. RiVive is manufactured under contract by Catalent in North Carolina and packaged in Indiana, with the device specifically engineered for ease of use by laypersons in community settings.

HRT's business model is structurally distinct from for-profit pharma: it sells RiVive at manufacturing cost with zero profit motive, accepting lower margins in exchange for public-health impact. Go-to-market relies on multi-channel distribution including direct e-commerce on its website, the Remedy Alliance harm reduction network, the three largest U.S. pharmaceutical wholesalers (Cardinal Health, McKesson, Cencora), group purchasing organizations (Capstone Health Alliance, MMCAP Infuse), and the A2A Alliance for federal and veterans-affairs entities. HRT is contractually obligated to donate at least 10% of annual production and has historically priced the two-dose pack at approximately $36 wholesale, with downward pricing pressure as scale increases.

Revenue mechanics are nonprofit-driven rather than equity-driven. The company has been funded primarily through a $9 million award from the Purdue Pharma bankruptcy estate, supplemented by Open Society Foundations and other philanthropic sources. Because HRT sells at cost and lacks a profit-line expansion lever, growth is fundamentally a function of volume, channel breadth, and grant funding rather than pricing power or market capture against competitors like Emergent BioSolutions' Narcan.

Name

Harm Reduction Therapeutics

Legal name

Harm Reduction Therapeutics, Inc.

Website

https://harmreductiontherapeutics.org

Company type

Private

Founded year

2017

Operating status

Operating

Headcount range

1–10 employees

Short description

Harm Reduction Therapeutics is a 501(c)(3) nonprofit pharmaceutical company that manufactures and distributes RiVive, an FDA-approved over-the-counter 3 mg naloxone nasal spray sold at cost to harm reduction programs, first responders, and public health agencies for opioid overdose reversal.

Ownership category

akta.pro rank

Product category

Over-the-Counter Pharmaceuticals (Opioid Overdose Reversal Medication)

NAICS

Pharmaceutical Preparation Manufacturing (325412), Drugs and Druggists' Sundries Merchant Wholesalers (42421)

SIC

Pharmaceutical Preparations (2834), Wholesale-Drugs, Proprietaries & Druggists' Sundries (5122)

akta.pro primary industry

Nasal Drug Delivery Devices (Sprays/Powder Devices) (HLAHAIAK)

akta.pro secondary industry

Pain Management & Anesthesiology Pharmaceuticals (HLAIAAAN)

Keywords

• Over-the-counter naloxone
• Opioid overdose reversal
• Compassionate dose naloxone
• Nonprofit pharmaceutical manufacturing
• Harm reduction therapeutics

Headquarters

HQ city

Bethesda

HQ country

United States

HQ region

North America

Offices3 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Supply Chain, Operations, Personnel, Technology or R&D, Marketing or Sales, Others

Revenue model

1. Product Sales at Cost: As the only 501(c)(3) non-profit pharmaceutical company manufacturing naloxone, HRT sells RiVive at manufacturing cost with zero profit. The price covers hard costs (inactive ingredients, nasal spray devices, vials, production, packaging, testing, warehousing, transportation - ~95%) plus minimal administration costs (~5%). Any cost savings from suppliers are passed directly to customers.

Pricing tiers

Go-to-market motion3 records

Distribution channels5 records

Marketing channels6 records

Core offering

HRT manufactures and distributes RiVive, an FDA-approved over-the-counter naloxone HCl nasal spray (3 mg per dose) for emergency treatment of opioid overdose. The product is sold as a twin pack of two single-dose intranasal devices, priced at manufacturing cost with zero profit because HRT operates as a 501(c)(3) nonprofit pharmaceutical company. At least 10% of annual production is donated free of charge through Remedy Alliance/For The People to underfunded harm reduction programs.

Product overview

Harm Reduction Therapeutics operates as a 501(c)(3) non-profit pharmaceutical company offering a single core product: RiVive OTC naloxone nasal spray 3 mg. RiVive is an FDA-approved emergency treatment for opioid overdose, sold at manufacturing cost without profit. The company also partners with the West Virginia Drug Intervention Institute (WVDII) to provide RiVive inside ONEbox emergency response kits, which include video-based overdose response training. Distribution occurs through direct orders via the company's website portal, as well as through multiple wholesale distributors and group purchasing organizations including Cardinal Health, McKesson, Cencora, Capstone Health Alliance, FFF Enterprises, A2A Alliance Pharmaceuticals, and MMCAP Infuse. The company donates at least 10% of projected annual production free of charge through Remedy Alliance/For The People.

Differentiator

Problem solved

Functional benefit

Brands

• RiVive: FDA-approved over-the-counter naloxone HCl nasal spray 3 mg for emergency treatment of opioid overdose. A compassionate dose naloxone product sold at cost by the nonprofit company.

Products and services

• RiVive (Naloxone HCl Nasal Spray 3 mg) FDA-approved over-the-counter (OTC) naloxone HCl nasal spray 3 mg for emergency treatment of opioid overdose. Sold as a twin pack carton containing two single-dose 0.1 mL intranasal devices, with 24 twin packs per case. Manufactured in North Carolina and packaged in Indiana. Sold at manufacturing cost with zero profit by the 501(c)(3) nonprofit pharmaceutical company. Available without prescription to harm reduction programs, treatment centers, first responders, public health agencies, community organizations, and government entities.

Quantifiable outcome

• Naloxone reverses overdoses in 98.8% of cases
• +3 more outcomes

Named customers1 record

Segments5 records

Ideal customer profiles4 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature3 records

Partnerships

Six partnerships are on record, tiered core and minor.

• Capstone Health AlliancecoreChannel Partner/ Reseller/ Distributor · 19 March 2026Partnership to expand access to life-saving OTC naloxone nationwide through Group Purchasing Organization network. Targets healthcare organizations and group purchasers.
• A2A Alliance PharmaceuticalscoreChannel Partner/ Reseller/ Distributor · 14 August 2024Strategic partnership to expand access to RiVive OTC naloxone to U.S. federal entities and veterans. A2A distributes through federal channels and serves veterans healthcare.
• West Virginia Drug Intervention Institute (WVDII)coreStrategic or Co-development Partner · 28 February 2024Partnership to provide low-cost RiVive 3 mg naloxone nasal spray inside ONEbox emergency response kits. ONEbox provides on-demand, one minute emergency video instruction in English and Spanish for bystander intervention and overdose response. Kit designed for display in common areas like fire extinguishers and defibrillators.
• Remedy Alliance/For The People (Donation)minorOthers · 9 August 2023HRT donated 200,000 RiVive naloxone doses to Remedy Alliance for free distribution to harm reduction programs across the United States.
• CatalentcoreTechnology or Integration · 24 March 2023Commercial supply agreement for naloxone nasal spray manufacturing. Catalent provides manufacturing capabilities for RiVive production.
• Remedy Alliance/For The PeoplecoreChannel Partner/ Reseller/ DistributorPrimary harm reduction distributor partner for RiVive. HRT works in partnership with RA to make RiVive available to all harm reduction programs at the same price as direct ordering. RA also offers intramuscular product. Donations of at least 10% of projected annual production are distributed through RA free of charge to underfunded harm reduction organizations.

Scale indicators7 records

Recent moves6 records

Expansion highlights5 records

Direct peers

• Emergent BioSolutions: Maker of Narcan, the category-leading OTC naloxone nasal spray. Emergent's Narcan is the most direct competitor to RiVive, sharing the same form factor, OTC channel, and end-user base, but with established shelf presence and a year head start on OTC.
• Amphastar Pharmaceuticals: Manufactures naloxone prefilled syringes and other injectable opioid antagonists. Competes in the same overdose-reversal category as RiVive via a different delivery format, frequently referenced as a lower-cost alternative to branded naloxone.
• Hikma Pharmaceuticals: Generic pharmaceutical manufacturer producing injectable and nasal naloxone products. Competes at a similar price tier across pharmacy and hospital channels with a broader generic injectables portfolio.

Broad incumbents

• Pfizer: Distributes Narcan OTC at scale and operates one of the largest U.S. OTC commercial footprints. A broad incumbent that overlaps with HRT only in the naloxone category but has materially larger marketing, sales, and DTC infrastructure.
• Teva Pharmaceutical Industries: Generic pharmaceutical giant with an established injectable naloxone product line. Operates across many therapeutic categories but is materially comparable to HRT specifically in the opioid antagonist / overdose reversal segment.

Emerging players

• Indivior: Specialty pharmaceutical company focused on opioid use disorder treatments and previously marketed Nalscue intranasal naloxone in select markets. Adjacent specialization in opioid-related therapeutics makes it a relevant emerging-comparator for HRT.

Others

• National Harm Reduction Coalition: National nonprofit focused on harm reduction advocacy, capacity-building, and resource dissemination. Allied with HRT in mission and often the conduit by which harm reduction organizations access RiVive.
• Catalent: Contract development and manufacturing organization (CDMO) that produces RiVive under a commercial supply agreement with HRT. A key enabling supplier rather than a competitor, but materially relevant as a single-source manufacturing partner.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks7 records

Key highlights7 records

Customer concentration

• Facebookfacebook.com/profile.php?id=61573865699780
• LinkedInlinkedin.com/company/harm-reduction-therapeutics
• Instagraminstagram.com/harmreductiontherapeutics
• Xx.com/HRTherapeutics

Revenue estimate

Valuation estimate

Number of profiles

Profiles7 records

Funding overview

Funding rounds1 record

Investors1 record

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Harm Reduction Therapeutics