Positive results have been reported from a phase 2a clinical study of hydrocortisone acetate (HA) and lidocaine hydrochloride (LH) as single agents and in combination (HA/LH) in patients with grade I or II hemorrhoids. If the combination cream is eventually approved by the FDA, it would be the first prescription product available for the treatment of hemorrhoids in the U.S.
In the randomized, double-blind study, 210 hemorrhoid patients were treated twice daily for 14 days with either placebo or one of six active drug treatments (i.e., two concentrations each of HA, LH, or HA/LH). The patients kept a diary of their symptoms. In addition, they were evaluated on the Global Score of Disease Severity (GSDS) scale as well as on their individual signs and symptoms of hemorrhoids (such as bleeding, pruritus, and overall pain and discomfort) and on the time to onset of symptom relief.
Within the first few days of treatment, the highest concentration of the HA/LH product was superior to placebo, as measured by the number of subjects experiencing a minimum of two levels of improvement from baseline on the GSDS scale. The study was not powered to detect statistical significance; however, the data suggested that the combination product may also perform better than HA or LH alone. The trend of HA/LH superiority over placebo was also generally consistent for the treatment of individual signs and symptoms of hemorrhoidal disease (i.e., bleeding, itching, pain, and overall discomfort).
Hemorrhoids are a common gastrointestinal disorder characterized by itching, pain, swelling, tenderness, and bleeding. Hemorrhoids affect nearly 5% of the U.S. population, with approximately 10 million persons annually reporting symptoms of hemorrhoidal disease. Of these individuals, approximately one third visit a physician for evaluation and treatment of their hemorrhoids. Data also indicate that peak prevalence for both sexes occurs from age 45 to 65 years, with a subsequent decrease after age 65. Caucasians are affected significantly more often than African-Americans.
Source: Citius Pharmaceuticals; February 1, 2016.