An estimated 9 million Americans suffer from difficulty swallowing, otherwise known as “dysphagia.”

Dysphagia becomes more prevalent with age, affecting up to 1 in 5 older adults; epidemiologic studies indicate that the numbers may be as high as 22% of the population over 50 years of age.

Dysphagia is usually caused by another health condition that affects the nervous system, such as a stroke, head injury, or dementia.

ED patients suffering from dysphagia resort to crushing VIAGRA® tablets prior to administration; Sildenafil Oral Spray satisfies an unmet medical need for this subset of ED patients.

Pulmonary arterial hypertension (PAH) is a rare, progressive disorder characterized by high blood pressure (hypertension) in the arteries of the lungs (pulmonary artery) for no apparent reason. The pulmonary arteries are the blood vessels that carry blood from the right side of the heart through the lungs. Symptoms of PAH include shortness of breath (dyspnea) especially during exercise, chest pain, and fainting episodes.

Sildenafil, is marketed by Pfizer as a treatment for PAH under the brand name Revatio®.  Sildenafil decreases the activity of PDE5, a substance produced in the lungs and other parts of the body that breaks down another substance called cyclic guanosine monophosphate (GMP). Cyclic GMP causes the blood vessels (arteries) to relax and widen, so that more cyclic GMP is available for the blood vessels inside the lungs, leading to relaxation, or widening, of those vessels, which in turn, decreases the pulmonary blood pressure to the heart and improves its function.

Revatio® is only available as a 20 mg pill. Sildenafil Oral Spray would be a welcome dosage form alternative for the PAH patient population, especially for those patients suffering from dysphagia.

When a baby is born, pressure in the blood vessels of the lungs is high; this pressure starts to fall when normal breathing is established. Sometimes, this transition does not occur, and pressure remains high, preventing blood from flowing to the lungs to deliver adequate oxygen, a life-threatening situation referred to as “persistent pulmonary hypertension” (PPHN) of the neonate.

PPHN occurs in as many as 6.8 of 1,000 live births. Mortality is approximately 10% to 20%. Sildenafil is prescribed “off label” to treat PPHN. Published studies have found that administration of sildenafil in PPHN is associated with a significant increase in the oxygenation and a reduction in mortality with no clinically important side effects.

Administration of sildenafil in infants is via continuous IV infusion. This parenteral fluid administration can be lifesaving; however, it also carries substantial risks, especially in newborns. Reported studies in infants have utilized preparation of sildenafil solution by crushing 50-mg tablets to improve administration of the drug. Our market research indicates that Sildenafil Oral Spray would be welcomed by pediatricians as an alternative, convenient route of administering sildenafil to infants.

Scleroderma, or systemic sclerosis, is a chronic connective tissue disease caused by the immune system mistakenly attacking healthy tissues, triggering vasoconstriction, or the narrowing of blood vessels. Complications include Raynaud’s phenomenon, a condition resulting in discoloration of the fingers and/or the toes, which results from reduced blood flow to the fingers or toes, leading to digital ulcers, or sores on the extremities that often become infected.

Sildenafil acts to dilate or widen the blood vessels and thereby improves oxygen transport throughout the body. Sildenafil 50mg tablet is prescribed “off label” to treat scleroderma. Reported studies have demonstrated that sildenafil relieved symptoms of Raynaud’s phenomenon in patients who were resistant to vasodilatory therapy, including speeding up the healing of digital ulcers. The advantages of Sildenafil Oral Spray as compared to sildenafil tablets apply equally to its application as a therapeutic agent for scleroderma.