SUD-004 : pulmonary arterial hypertension

SUD-004 is based on the DuroMist™ oral spray formulation of sildenafil and is designed to treat pulmonary arterial hypertension (PAH) in adults. With PAH, the blood pressure in your lungs is too high and your heart has to work hard to pump blood into your lungs. Sildenafil improves the ability to exercise and slows down worsening changes in your physical condition. Sildenafil is marketed in tablet form as Revatio® for PAH by Pfizer.

Sildenafil works in the treatment of PAH by inhibiting PDE-5 produced in the lungs. This breaks down cyclic GMP, causing the blood vessels in the lungs to relax and widen. This, in turn, makes it easier for the heart to pump blood through the lungs and reduces blood pressure, which leads to improvement in patients’ physical activity levels and well being.

The recommended dose for sildenafil as Revatio® in the pill form for treatment of PAH is 20 mg (one pill) taken orally three times a day. SUD-004 is formulated such that each actuation delivers 10mg of sildenafil, which is sprayed directly in the mouth over the tongue.

The pharmacokinetic (PK) data generated with DuroMist™ successfully demonstrated that the 20mg dose (two sprays) of sildenafil was effectively absorbed through the oral mucosa. Also, DuroMist™, and thus also SUD-004, demonstrated an excellent safety profile and was well tolerated in the PK study at all dose levels.

Sales of therapies to treat PAH, a rare but life-threatening disorder, are estimated to reach $3.5 billion over the next 10 years. Pfizer’s Revatio® tablets for PAH in the USA generated sales of US$340 million in the 12 months to 30 September 2012, which was the month that Pfizer lost marketing exclusivity, hence opening the market to generic competition.

If you are interested to learn more about SUD-004 please email This email address is being protected from spambots. You need JavaScript enabled to view it. (Chief Business Officer).