SafeRx Pharmaceuticals

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.

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

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

• Opioid overdose prevention
• Alcohol-resistant opioids
• Fixed-dose combination drugs
• Pain management pharmaceuticals
• Opioid use disorder

Headquarters

HQ city

Lenox

HQ country

United States

HQ region

North America

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. 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

Core 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™

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature8 records

Recent moves5 records

Expansion highlights5 records

Direct 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

• Xx.com/saferx_pharma
• Facebookfacebook.com/SafeRxPharma
• LinkedInlinkedin.com/company/saferx-pharma

Revenue estimate

Valuation estimate

Number of profiles

Profiles1 record

Funding overview

Funding rounds1 record

Investors

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 SafeRx Pharmaceuticals