SafeRx Pharmaceuticals
SafeRx Pharmaceuticals is a development-stage, pre-revenue drug company founded in 2021 that is developing a patented fixed-dose combination ARO Platform pairing opioids with disulfiram to deter alcohol co-ingestion in pain and OUD patients. It is pursuing FDA 505(b)(2) approval via partner Camargo Pharmaceutical Services.
- Company typePrivate
- Founded2021
- HeadquartersLenox, United States
- Headcount1–10
- GTM typeB2B
- OfferingHardware or Manufacturing
What SafeRx Pharmaceuticals does
SafeRx Pharmaceuticals Inc. is a development-stage, privately held pharmaceutical company founded in 2021 and headquartered in Lenox, Massachusetts, pursuing FDA approval of a proprietary Alcohol-Resistant Opioid (ARO) Platform. The company targets the previously unaddressed interaction between opioids and alcohol consumption — a combination the CDC links to roughly one in four prescription opioid overdoses. Its core technology is a patented fixed-dose combination platform that pairs an FDA-approved opioid (methadone, buprenorphine/naloxone, oxycodone, morphine, or hydrocodone) with disulfiram (an aldehyde dehydrogenase inhibitor) inside a matrix-based tablet engineered to prevent physical or chemical separation of the two active ingredients. This yields five pipeline candidates branded MethARO™, BupARO™, OxARO™, MorphARO™, and HydARO™, intended respectively for opioid use disorder with optional pain application, OUD-only, and moderate-to-severe pain management in patients where enforced alcohol abstinence is desired.
The company is pursuing accelerated FDA approval via the 505(b)(2) regulatory pathway in partnership with Camargo Pharmaceutical Services, with the inaugural candidate MethARO™ previously targeted for approval by early 2024. SafeRx has no commercial revenue and no approved products; operations are funded through an equity crowdfunding campaign (investinsaferx.com) that had raised approximately $51,893 as of May 2022, against an undisclosed target. The go-to-market strategy is event-driven and community-led rather than commercial — Dr. Michael Presti (Founder/CEO) drives awareness via five podcast appearances, Forbes coverage, and conference exhibition (2021 FSIPP/FSPMR Annual Conference), with a dedicated physician-inquiry channel signaling an anticipated specialty-physician-targeted launch post-approval. Headcount is 1-10 employees, the cap table is retail/crowdfunding-driven with no disclosed institutional lead investors, and no ownership, valuation, or commercial partnership details are publicly available.
SafeRx Pharmaceuticals firmographics
Firmographics- Name
- SafeRx Pharmaceuticals
- Legal name
- SafeRx Pharmaceuticals Inc.
- Website
- https://saferxpharmaceuticals.com
- Company type
- Private
- Founded year
- 2021
- Operating status
- Operating
- Headcount range
- 1–10 employees
- Short description
- SafeRx Pharmaceuticals is a development-stage, pre-revenue drug company founded in 2021 that is developing a patented fixed-dose combination ARO Platform pairing opioids with disulfiram to deter alcohol co-ingestion in pain and OUD patients. It is pursuing FDA 505(b)(2) approval via partner Camargo Pharmaceutical Services.
- Ownership category
- akta.pro rank
SafeRx Pharmaceuticals industry classification
Industry- Product category
- Specialty Pharmaceuticals
- NAICS
- Pharmaceutical and Medicine Manufacturing (3254), Pharmaceutical Preparation Manufacturing (325412)
- akta.pro primary industry
- Pharmacovigilance, Medication Safety & Controlled Substance Diversion Monitoring (HLAFALAN)
- akta.pro secondary industry
- Medication-Assisted Treatment (MAT) & Opioid Treatment Programs (OTPs) (HLAFACAG)
Keywords
Where SafeRx Pharmaceuticals is headquartered
LocationHeadquarters
- HQ city
- Lenox
- HQ country
- United States
- HQ region
- North America
Markets served
SafeRx Pharmaceuticals business model
Business model- GTM type
- B2B
- Offering type
- Hardware or Manufacturing
- Cost components
- Technology or R&D, Personnel, Operations, Marketing or Sales, Others
Revenue model
- Future Pharmaceutical Product Sales (pre-revenue): SafeRx is a development-stage pharmaceutical company with no current product revenue. Future revenue is expected to come from the sale of approved ARO pharmaceutical products (MethARO™, BupARO™, OxARO™, MorphARO™, HydARO™) once FDA approval is achieved. The company is currently pre-revenue and funding operations through equity crowdfunding.
Go-to-market motion3 records
SafeRx Pharmaceuticals product offering
Product offeringCore offering
SafeRx Pharmaceuticals develops a proprietary Alcohol-Resistant Opioid (ARO) Platform composed of fixed-dose combination drug candidates that pair an FDA-approved opioid (methadone, buprenorphine/naloxone, oxycodone, morphine, or hydrocodone) with disulfiram in a tamper-resistant matrix-based tablet that prevents physical or chemical separation of the two active ingredients. The platform targets the opioid-and-alcohol co-ingestion dimension of the U.S. opioid crisis, with lead candidate MethARO™ pursuing accelerated FDA approval via the 505(b)(2) regulatory pathway in partnership with Camargo Pharmaceutical Services.
Product overview
SafeRx Pharmaceuticals is a development-stage pharmaceutical company offering a single unified proprietary platform — the ARO (Alcohol-Resistant Opioid) Platform — which is built around five pipeline candidates: MethARO™, BupARO™, OxARO™, MorphARO™, and HydARO™. Each candidate is a fixed-dose combination of an FDA-approved opioid (methadone, buprenorphine/naloxone, oxycodone, morphine, or hydrocodone) with disulfiram, delivered via a matrix-based tablet that prevents separation of the two active ingredients. The platform is intended for treatment of opioid use disorder and/or moderate-to-severe pain refractory to non-opioid therapy in patients where enforced sobriety from alcohol is desired, with MethARO™ targeted as the inaugural product pursuing accelerated FDA approval via the 505(b)(2) pathway.
Differentiator
Problem solved
Functional benefit
Brands
- MethARO™: ARO product candidate combining methadone HCl and disulfiram; SafeRx's inaugural product targeting FDA approval by early 2024 for opioid use disorder and/or pain in patients in whom enforced sobriety from alcohol is desired.
- BupARO™
- OxARO™
- MorphARO™
- HydARO™
- ARO Platform
Products and services
- ARO Platform (Alcohol-Resistant Opioid Platform) Proprietary patented platform of fixed-dose combination Alcohol-Resistant Opioids (AROs) pairing an FDA-approved opioid (MOR agonist) with disulfiram (an aldehyde dehydrogenase inhibitor) inside a matrix-based tablet that prevents separation of the two active ingredients, targeting the previously unaddressed interaction between alcohol and opioids that the CDC links to nearly one in four prescription opioid overdoses.
- MethARO™
Companies that use SafeRx Pharmaceuticals
Customer profileIdeal customer profiles2 records
SafeRx Pharmaceuticals technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Feature8 records
SafeRx Pharmaceuticals partnerships and signals
Strategic signalRecent moves5 records
Expansion highlights5 records
SafeRx Pharmaceuticals competitors and assessment
Company assessmentDirect peers
- Indivior: Global leader in opioid use disorder treatment (Suboxone, Sublocade). Directly comparable to SafeRx as a developer of opioid-based therapeutics for OUD, with a much larger commercial footprint and pipeline.
- Collegium Pharmaceutical: Specialty pharma commercializing abuse-deterrent opioid formulations (e.g., Xtampza). Comparable as a developer of differentiated opioid pain therapeutics with safety/tamper-resistance positioning.
- Alkermes: Developer of Vivitrol (naltrexone) for opioid and alcohol use disorders. Comparable as a specialty pharma building differentiated therapeutics for substance use disorders, including alcohol-related indications.
- Braeburn: Specialty pharma focused on serious disorders of the central nervous system, including OUD treatments such as Brixadi (buprenorphine). Directly comparable as a developer of long-acting opioid-based therapies for OUD.
- Camurus: Swedish specialty pharma developing Buvidal/Sublocade-class long-acting buprenorphine depots for opioid dependence. Comparable as an innovator in opioid-use-disorder therapeutics with platform-based product extensions.
Emerging players
- Omeros Corporation: Mid-stage biopharma with assets in pain and inflammation. Comparable as a smaller clinical-stage company developing opioid-sparing or differentiated pain therapeutics.
- BioXcel Therapeutics: Clinical-stage biopharma using AI-driven drug repurposing in neuroscience, including agitation and substance-use-related indications. Comparable as an early-stage platform biotech targeting CNS/substance-use disorders.
- Titan Pharmaceuticals: Developer of Probuphine, a subdermal buprenorphine implant for OUD maintenance. Comparable as a small-cap innovator in opioid-use-disorder drug delivery, though at a later commercialization stage than SafeRx.
- US WorldMeds: Specialty pharma with products in substance use disorder (e.g., Lucemyra for opioid withdrawal). Comparable as a focused developer of therapies targeting opioid-use-related conditions.
Broad incumbents
- Mallinckrodt Pharmaceuticals: Large specialty pharma with a meaningful opioid pain and addiction-treatment portfolio. Comparable at the category level as an established opioid therapeutics player, though far broader and later-stage than SafeRx.
Market position
Strengths4 records
Weaknesses5 records
Competitive moat3 records
Key risks2 records
Key highlights6 records
Customer concentration
SafeRx Pharmaceuticals social profiles
Digital presenceSafeRx Pharmaceuticals financial estimates
Financial estimateRevenue estimate
Valuation estimate
SafeRx Pharmaceuticals leadership team
Management profileNumber of profiles
Profiles1 record
SafeRx Pharmaceuticals funding detail
Funding detailFunding overview
Funding rounds1 record
Investors
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
SafeRx Pharmaceuticals 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 SafeRx Pharmaceuticals
What does SafeRx Pharmaceuticals do?
SafeRx Pharmaceuticals develops a proprietary Alcohol-Resistant Opioid (ARO) Platform composed of fixed-dose combination drug candidates that pair an FDA-approved opioid (methadone, buprenorphine/naloxone, oxycodone, morphine, or hydrocodone) with disulfiram in a tamper-resistant matrix-based tablet that prevents physical or chemical separation of the two active ingredients. The platform targets the opioid-and-alcohol co-ingestion dimension of the U.S. opioid crisis, with lead candidate MethARO™ pursuing accelerated FDA approval via the 505(b)(2) regulatory pathway in partnership with Camargo Pharmaceutical Services.
Is SafeRx Pharmaceuticals a public or private company?
SafeRx Pharmaceuticals is a private company. It is classified as founder individual operated bootstrapped and is currently operating.
When was SafeRx Pharmaceuticals founded?
SafeRx Pharmaceuticals was founded in 2021. It employs 1 to 10 people.
Where is SafeRx Pharmaceuticals based?
SafeRx Pharmaceuticals is headquartered in Lenox, United States, in the North America region.
How does SafeRx Pharmaceuticals make money?
One revenue line is on record: future Pharmaceutical Product Sales (pre-revenue).
Who are SafeRx Pharmaceuticals's main competitors?
Direct peers on record are Indivior, Collegium Pharmaceutical, Alkermes, Braeburn and Camurus. Emerging players are Omeros Corporation, BioXcel Therapeutics, Titan Pharmaceuticals and US WorldMeds. Mallinckrodt Pharmaceuticals is listed as a broad incumbent.
Does SafeRx Pharmaceuticals have an API?
No public API is recorded for SafeRx Pharmaceuticals.
What industry is SafeRx Pharmaceuticals in?
SafeRx Pharmaceuticals's product category is Specialty Pharmaceuticals. Its primary akta.pro industry code is HLAFALAN, Pharmacovigilance, Medication Safety & Controlled Substance Diversion Monitoring, with a secondary code of HLAFACAG, Medication-Assisted Treatment (MAT) & Opioid Treatment Programs (OTPs). Its NAICS code is 3254.