Our client has developed a subcutaneous testosterone implant system that overcomes disadvantages with competing HRT products.

The system consists of 100mg pellets and a specialized implantation trocar.

The pellets offer the following advantages:

  • 3-month slow release
  • Much higher absorption rate than patches or gels
  • Fewer pellets required to achieve the required dose
  • Larger pellets are less likely to extrude through the skin

Current Situation:

  • Currently available testosterone dosage forms used for hormone replacement therapy (HRT) are inconvenient and may cause dangerous side effects.
  • Testosterone gels and creams may cause adverse reactions at the application site, including burning, blistering, itching, soreness, swelling, redness, rash, dry skin, and acne.
  • Additionally, gels and creams may transfer to others through contact with skin and clothing, which can be particularly dangerous for women and children.
  • Existing 75mg testosterone implants require 2 to 6 pellets (150mg – 450mg total dosage) and are susceptible to extrusion through the skin at or near the implantation site.

Solution:

  • Our client is currently the sole manufacturer of this testosterone pellet formulation, with a manufacturing facility in the United States.
  • The product is presently being exported to the United Kingdom.
  • The companion implantation trocar was listed with the US FDA in 2017.
  • Our client wishes to manufacture and supply the product to partners via supply or purchase agreements.
  • All markets are available for partnering aside from the United Kingdom.