Pre-Clinical Safety of Sensum+:

Sensum+ has been studied in multiple animal safety models. Below is a list of important safety studies conducted on the product.

Safety of Sensum+ on Mice Tails:

Sensum+ was applied to tails of mice for fourteen (14) consecutive days and the effect of the product was analyzed visually and by histopathology by a Board Certified Pathologist. Epidermal thickness was evaluated from the mid-section of the tail for each animal. The thickness was measured from the basement membrane to the top of the stratum corneum, excluding the overlying keratin layer. Epidermal thickness was determined from four locations of interfollicular epidermis representing the dorsal, ventral, lateral, and medial aspects of the cross section of the tail. The H&E-stained tail sections were examined microscopically and histopathologically. There was no evidence of epidermal irritation (i.e., hyperplasia, hyperkeratosis, dermal inflammation) associated with topical administration of Sensum+ Cream or Placebo Cream.

Effect of Sensum+ on Body Weights of Animals:

Body weights of animals were measured pre and daily post dose with placebo and Sensum+ treatment. There was no statistical difference between the weights of animals in the two groups and therefore, Sensum+ treatment had no effect on the body weight of animals as shown in the Graph below.

Safety of Sensum+ on Non-Human Primates:

The effect of treatment and reversibility associated with Sensum+ or placebo was assessed on the vaginal pH/flora of non-nave female cynomolgus non-human primates (NHP) when applied twice-daily (BID) for a period of 14 days.
During the in-life period, the animals were observed daily for mortality and moribundity. Individual body weights were collected weekly throughout the study. Detailed clinical examinations were conducted daily prior to dosing throughout the study.
Menstrual cycles were synchronized in all primates via 30 mg of Depo-Provera (medroxyprogesterone acetate) intramuscular injection (IM) at least 14 days prior to dose administration and again 7 days post-dose, which reduces the influence of menstrual cycle on study results. One group received placebo and the other group received Sensum+. Animals were then dosed twice per day (BID) for 14 days followed by a 14-day recovery. The animals were dosed with 0.5 mL of the Placebo Cream or Sensum+ Cream.
Vaginal pH was measured daily for 5 days prior to Day 1, and then prior to dose administration on Days 1, 8, and 15. A vaginal swab for flora evaluation was conducted pre-dose, and prior to dose administration on Days 1, 8, 15, and 29.
The day after the end of dosing (Day 15) and on the day after the last day of the 14-day recovery period (Day 29), vaginal pH and a vaginal swab was collected from each animal from the alternating locations and total flora was assessed.

Effect of Sensum+ on Body Weights of Animals:

All animals were observed to be clinically normal for the duration of the study. There were no test article-related effects on body weight as shown in the table below.

Effect of Sensum+ on Body Weights of Animals:

The vaginal pH means were consistent through all groups (~7.2) for the duration of the study confirming that Sensum+ has no effect on the vaginal pH as shown in the Figure below.

Effect of Sensum+ on Vaginal Flora:

NHP vaginal swab inoculum collected at Days 1, 8 and 29 post start of treatment were cultured in LB medium for up to 7 days. Bacterial growth was observed over time in all treatment groups. No statistical difference was observed between placebo and treatment groups as shown on the figure below.


Based on the results of this study, daily BID vaginal dose administration of Sensum+ Cream for 14 days had no effect on the vaginal pH and vaginal bacterial growth of female cynomolgus NHPs in comparison to placebo cream. In addition, no adverse events observed following a 14 day treatment-free period.

Human Safety Information:

The Sensum+ formulation contains ingredients which are Generally Recognized As Safe (GRAS) by the US Food and Drug Administration. Sensum+ does not contain chemically synthesized drug as ingredient. Sensum+ is a cream applied topically, there is no risk of interaction with other drugs systemically. To ensure purity and quality, Sensum+ is produced following GMP (Good Manufacturing Practices) guidelines in an FDA-registered facility. After 14 days of treatment twice daily, Sensem+ was well tolerated by the majority of subjects with no serious adverse effects. 14.8% of subjects reported mild burning sensation of the glans or vagina, which subsided within minutes.