Development

FemmePharma Global Healthcare’s mission is to create value by developing innovative “women-friendly” products in areas of high unmet need, low penetration by existing therapeutic options and high clinical value for women. Below are just a few of the near term therapeutic areas FemmePharma Global Healthcare is currently pursuing. The Company intends to continue researching areas that match the Company’s mission.

Learn more about women’s diseases and disorders in the field of women’s healthcare by clicking on one of the therapeutic areas below:

FemmePharma offers a unique combination of promising, unencumbered, late-stage clinical products with relatively low regulatory risk and which can be successfully developed and launched with relatively low spend. The Company is currently planning for a Phase III trial of its lead product, FP1097: a potentially fast-acting, long-lasting treatment of urinary incontinence that is delivered intravaginally with no vaginal irritation or leakage of drug. In Phase II, FP1097 demonstrated a clinically meaningful reduction of 25% in the number of micturitions, a 75% reduction in incontinence episodes and a significant reduction in side effects to systemic treatments across all three dosage levels. Most notably, no patients experienced dry mouth at the lowest dose studied, whereas 61% of patients treated with the oral form of the drug experienced dry mouth. The Company also conducted a Phase II trial of FP1198 for the treatment of pain associated with fibrocystic breast disease (“FBD”). FP1198 has demonstrated minimal observable side effects and a reduction in pain and tenderness.

Each of FemmePharma’s products are being developed or are expected to be developed under the 505(b)(1) or 505(b)(2) regulatory pathways and will require NDA submissions prior to obtaining marketing authorization.

For its two most advanced development products, the Company has clearly demonstrated how its drug development strategy—combined with the advantages of its delivery technologies—has led to the accelerated and cost efficient development of attractive drug products.

Patented Technology

The technological and innovative core of the Company is its platform technology found in its U. S. and international patents. This is a unique method of drug delivery that is highly effective in treating women’s diseases and disorders that are amenable to a local or regional approach, including pelvic disease, breast disease and reproductive system diseases and disorders. This technology improves the methods of use and formulations of drugs. The benefit of this invention is that an effective amount of drugs may be administered in a very small volume directly to a targeted disease or disorder area. The drug classes covered include a broad spectrum of those that are used in the treatment of women’s diseases and disorders of the female pelvic and reproductive organs.

PARDEL™ (Pelvic and Reproductive Delivery) is one of the Company’s patented platform technologies. PARDEL™ delivers the drug directly to the pelvic and reproductive areas, with preferred absorption and migration into the affected areas.

For drugs given locally to treat pelvic disease and reproductive system diseases and disorders, such a delivery system may result in a reduction of side effects by lowering the dose and bypassing significant systemic circulatory levels.

Mini Volume Applicator

Mini volume applicator that’s ideal for dispensing very small (less than 1ml.) of medication.
Applicator has been specially designed with a woman in mind.

  • Single use
  • Disposable
  • Convenient and portable (about the size of a tampon)
  • Made and tested in the USA
  • Approved Medical Grade Polymers
  • Delivers 100% of contents
  • Patented applicator
  • May also be used as a vaginal dilator
  • Available in white or clear

Comes in units of 5.

In interested in our patented applicator, please contact us for more information.

DERMODEL™ is targeted to a specific region of disease or disorder; in this case, a dermal delivery to a specific region of the body. It does not require patches or special devices to allow drugs to penetrate the skin and reach the areas of disease or disorder. The DERMODEL™ technology will provide local delivery of a pharmaceutically acceptable agent without many of the associated side effects seen by other transdermally delivered products.