Sildenafil : Erectile Dysfunction/PAH

SUDA’s ED/PAH project, DuroMist™ is a first-in-class oral spray formulation of sildenafil (marketed in tablet form by Pfizer under the brand name Viagra®), sprayed directly in the mouth over the tongue for the treatment of erectile dysfunction (ED). The DuroMist™ dosage form is a metered spray that offers the potential for increased patient convenience, reduced food effect and lower dose.

Sildenafil is the largest selling drug globally for ED and is also approved to treat pulmonary arterial hypertension. Sildenafil acts by inhibiting phosphodiesterase type 5 (PDE5), an enzyme that promotes degradation of cyclic guanosine monophosphate (cGMP), which regulates blood flow.

SUDA has undertaken a Pilot PK Study. A summary of work performed highlighted:

  • Bioequivalent to tablet
  • Primary care physicians prefer oral spray vs. tablets. Potential for significant market share gain if food-effect is avoided
  • Patent-protected, first in class oral spray of sildenafil
  • Excellent safety and well tolerated
  • Taste-masked, flavoured, convenient and easy to administer
  • Manufacturing process in place with scale-up capability and test methods developed and validated
  • Active IND and 505(b)(2) pathway to registration

Based on primary market research:

  • Results of the survey indicated that 42% of primary care physicians (PCPs) would be likely to prescribe a spray formulation for ED with that % increasing to >66% based on the following criteria, in order of importance:
      • Faster onset
      • Reduced side effects
      • Limited or no food effect
      • Easier and more convenient to use