Harm Reduction Therapeutics
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.
- Company typePrivate
- Founded2017
- HeadquartersBethesda, United States
- Headcount11–50
- GTM typeB2B
- OfferingHardware or Manufacturing
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.
Harm Reduction Therapeutics firmographics
Firmographics- 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
- 11–50 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
Harm Reduction Therapeutics industry classification
Industry- 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
Where Harm Reduction Therapeutics is headquartered
LocationHeadquarters
- HQ city
- Bethesda
- HQ country
- United States
- HQ region
- North America
Offices3 records
Markets served
Harm Reduction Therapeutics business model
Business model- GTM type
- B2B
- Offering type
- Hardware or Manufacturing
- Cost components
- Supply Chain, Operations, Personnel, Technology or R&D, Marketing or Sales, Others
Revenue model
- 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
| Model | Billing | Price |
|---|---|---|
| Unit Pricing | Pay-as-you-go | Case pricing - minimum 1 case (24 twin packs) |
| Other | Pay-as-you-go | Non-profit/charitable pricing |
Go-to-market motion3 records
Distribution channels5 records
Marketing channels6 records
Harm Reduction Therapeutics product offering
Product offeringCore 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
Companies that use Harm Reduction Therapeutics
Customer profileNamed customers1 record
Segments5 records
Ideal customer profiles4 records
Harm Reduction Therapeutics technology and API
TechnologyTechnology focussed No
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Feature3 records
Harm Reduction Therapeutics partnerships and signals
Strategic signalPartnerships
Six partnerships are on record, tiered core and minor.
- Capstone Health AlliancecorePartnership to expand access to life-saving OTC naloxone nationwide through Group Purchasing Organization network. Targets healthcare organizations and group purchasers.
- A2A Alliance PharmaceuticalscoreStrategic 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)corePartnership 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)minorHRT donated 200,000 RiVive naloxone doses to Remedy Alliance for free distribution to harm reduction programs across the United States.
- CatalentcoreCommercial supply agreement for naloxone nasal spray manufacturing. Catalent provides manufacturing capabilities for RiVive production.
- Remedy Alliance/For The PeoplecorePrimary 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
Harm Reduction Therapeutics competitors and assessment
Company assessmentDirect 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
Harm Reduction Therapeutics social profiles
Digital presenceHarm Reduction Therapeutics financial estimates
Financial estimateRevenue estimate
Valuation estimate
Harm Reduction Therapeutics leadership team
Management profileNumber of profiles
Profiles7 records
Harm Reduction Therapeutics funding detail
Funding detailFunding overview
Funding rounds1 record
Investors1 record
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
Harm Reduction Therapeutics M&A and investment
M&A and investmentM&A
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about Harm Reduction Therapeutics
What does Harm Reduction Therapeutics do?
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.
Is Harm Reduction Therapeutics a public or private company?
Harm Reduction Therapeutics is a private company. It is classified as nonprofit foundation owned and is currently operating.
When was Harm Reduction Therapeutics founded?
Harm Reduction Therapeutics was founded in 2017. It employs 11 to 50 people.
Where is Harm Reduction Therapeutics based?
Harm Reduction Therapeutics is headquartered in Bethesda, United States, in the North America region.
How does Harm Reduction Therapeutics make money?
One revenue line is on record: product Sales at Cost.
Who are Harm Reduction Therapeutics's main competitors?
Direct peers on record are Emergent BioSolutions, Amphastar Pharmaceuticals and Hikma Pharmaceuticals. Broad incumbents are Pfizer and Teva Pharmaceutical Industries. Indivior is listed as an emerging player. Others are National Harm Reduction Coalition and Catalent.
Does Harm Reduction Therapeutics have an API?
No public API is recorded for Harm Reduction Therapeutics.
What industry is Harm Reduction Therapeutics in?
Harm Reduction Therapeutics's product category is Over-the-Counter Pharmaceuticals (Opioid Overdose Reversal Medication). Its primary akta.pro industry code is HLAHAIAK, Nasal Drug Delivery Devices (Sprays/Powder Devices), with a secondary code of HLAIAAAN, Pain Management & Anesthesiology Pharmaceuticals. Its NAICS code is 325412 and its SIC code is 2834.