About MelioOne®

Targeted intrauterine therapy for primary dysmenorrhea, menstrual pain

THE CONCEPT

MelioOne® is an investigational drug-led therapy for severe menstrual pain

It combines a proven anti-inflammatory (NSAID) drug component with an established delivery route in a novel way to treat dysmenorrhea at its source, delivering ~200 mg of celecoxib over 36 months via a 5-minute insertion, with minimal systemic exposure.

  • Celecoxib is an anti-inflammatory drug approved in 1998, with roughly 30 years of safety and efficacy data.

  • Globally, 40-60% of women with dysmenorrhea take NSAIDs to manage menstrual pain

Proven NSAID API

  • Intrauterine delivery and device insertion mechanisms have been an approved route since 1984

  • 160 million women use IUDs for contraception globally

  • We are reimagining the IUD as a delivery mechanism to target drug release at the site of inflammation

Targeted polymer carrier

Dysmenorrhea is an inflammatory issue, not a reproductive issue.

HOW IT WORKS

Chronic inflammation is the common denominator

  • Progesterone withdrawal before menstruation promotes the production of prostaglandins in the uterus through the activation of COX-2. ​

  • This initiates prostaglandin synthesis, triggering a strong inflammatory response in the uterus, stimulating uterine contractions, and reducing blood flow, which causes dysmenorrhea.​

  • MelioOne® aims to deliver a low dose of anti-inflammatory medication directly into the uterus to modulate prostaglandin production. ​

  • By inhibiting COX-2, we disrupt prostaglandin synthesis and reduce the inflammatory response in the uterus.

References:

1 Clin. Exp. Obstet. Gynecol. 2023; 50(12): 274.
2 Expert Opin Investig Drugs. 2024 Apr;33(4):347-357.
3 Int J Biol Sci. 2019 Oct 23;15(13):2783–2797. 
4 Reprod Med Biol. 2019 Jun 18;18(4):305-311. 3) Eur J Obstet Gynecol Reprod Biol. 2004;116(1):100‐102.

Frequently Asked Questions (FAQ)

  • MelioOne® is not intended as a contraceptive. It is designed as a hormone-free intrauterine therapy to address and downregulate local inflammation that causes period pain. 

  • Because MelioOne® uses a T-shaped intrauterine frame, the physical sensation during placement will be comparable to that of standard intrauterine devices (IUDs).  
     
    Insertion pain is a well-documented occurrence in IUD insertion and is not to be taken lightly. Following ACOG’s latest guidelines, practitioners are advised to offer anesthesia to patients before IUD insertion. Likewise, patients are advised to check with practitioners on what sort of anesthesia is offered prior to insertion. 

  • MelioOne® is targeting sustenance for a minimum of 12 months before needing replacement. The final duration will be determined by clinical trial outcomes. 

  • MelioOne®’s specific safety profile will be determined through the outcomes of the clinical trials. 

  • No it is not. MelioOne® is an investigational drug-led drug-device combination, currently in preclinical stage of development.  
     
    It has not passed regulatory approval from neither the FDA or EMA and is not yet available in market. 

  • Pricing details are not finalized and is dependent on pricing dynamics and different distribution models.