Medical Need (Halo-Lido)

Hemorrhoidal disease is the most common cause of rectal bleeding in adults and generally one of the most frequent diagnoses in almost any anorectal complaint. Although hemorrhoids and other anorectal diseases are not life-threatening, individual patients can suffer from agonizing symptoms such as painful defecation, burning pain, itching with the urge to scratch (perianal pruritus), weeping of the wound and bleeding, which can limit social activities and have a negative impact on quality of life.

internal external hemorrhoids

Who is at Risk for Hemorrhoids?

Certain patient populations are at particularly high risk for hemorrhoids:

  • At any time, up to 5% of the US population suffers from hemorrhoids.
  • By age 50, about half of adults have had to deal with the itching, discomfort and bleeding that can signal the presence of hemorrhoids.
  • Over 10 million patients admit to symptoms of hemorrhoidal disease, and one-third of them seek physician treatment.

Although hemorrhoids are not life-threatening, individual patients can suffer agonizing symptoms which can limit social activities and have a negative impact on quality of life.

If Citius Pharmaceuticals receives FDA approval for its topical halobetasol-lidocaine combination formulation for the treatment of hemorrhoids, it may qualify for three years of market exclusivity for its dosage strength and formulation. In that case, Citius may be the only product on the market proven to be safe and effective for the treatment of hemorrhoids.