Desert Harvest Seeks FDA Approval for Super-Strength Aloe Vera Capsules to Treat Interstitial Cystitis

ELLSWORTH, Maine, Sept. 1, 2021 /PRNewswire/ -- Desert Harvest, a manufacturer of nutritional supplements formulated with a proprietary super-concentrated aloe vera extract, is seeking approval from the U.S. Food and Drug Administration (FDA) for use of its Super-Strength Aloe Vera Capsules in the treatment of interstitial cystitis (IC), the painful chronic bladder condition that affects as many as 12 million men and women.

FDA approval would make Desert Harvest's product the first FDA-approved IC treatment alternative to pentosan polysulfate sodium (Elmiron) and the first prescription IC therapy not developed by a pharmaceutical company.

Desert Harvest Super-Strength Aloe Vera Capsules were developed specifically to help people suffering from interstitial cystitis, uniquely providing 600 mg of 100% organically grown aloe vera per capsule. Multiple studies have shown that the product helps relieve IC symptoms such as pelvic pain, urethral burning, and urgency and frequency of urination in a large majority of patients.

A 1995 double-blind, placebo-controlled study conducted with The Urology Wellness Center in Rockville, MD, found that 87.5% of patients who completed the study experienced relief from some of their symptoms, with 50% experiencing significant relief and able to return to a more normal lifestyle. A 2016 survey conducted in partnership with the Interstitial Cystitis Association reported symptom relief in 92% of patients, with 63% citing substantial improvement in urination urgency and frequency and nearly 70% achieving substantial improvements in pelvic pain and burning.

Both studies showed significantly higher efficacy as well as faster symptom relief with Desert Harvest's aloe vera capsules than with pentosan polysulfate sodium. The most comprehensive study of pentosan polysulfate sodium found that just 54.2% of participants reported a 50% improvement in IC symptoms.

In June, Desert Harvest received approval from the FDA and the Wake Forest Institutional Review Board to conduct a double-blind, placebo-controlled Phase 2 clinical trial to further validate the product's value for IC treatment. The new study is now under way at Wake Forest Baptist Health, part of Wake Forest University, in Winston-Salem, N.C.

Over a six-month period, 100 patients will be given either a regimen of Desert Harvest Super-Strength Aloe Vera Capsules or a placebo. The study will measure changes in IC symptoms, suprapubic pain, urinary frequency, sexual functioning and satisfaction, and perceived quality of life. A portion of the study also will examine the impact of increasing and decreasing dosage.

That study is expected to be completed in early 2023, paving the way for FDA review.

"Our super-concentrated oral aloe vera is recommended by doctors worldwide as a supplement for IC symptom relief, and we speak to customers every day who tell us that our product has helped them control months or years of debilitating pain and disruption to their daily routines," said Heather Florio, CEO of Desert Harvest. "With FDA approval, our product would become a first-line treatment that would help many more IC patients live more normal lives."

About Desert Harvest
Desert Harvest is a provider of nutritional supplements and natural skincare products utilizing a proprietary, whole-leaf, super-strength aloe vera extract that delivers benefits not available from products made with diluted, partial-leaf aloe. Backed by science and extensive research, the company's products are used for underserved and under-recognized conditions ranging from interstitial cystitis to radiation dermatitis and other women's health and sexual health ailments. The company was founded in 1993 and is based in Hillsborough, N.C. For more information, visit www.desertharvest.com.

SOURCE Desert Harvest