Prescription Cough
Focusing on a Non-Narcotic Cough Medicine with a Differentiated and Preferred Product Profile
Cough is one of the Top 5 specific reasons that a patient seeks a doctor visit according to 2016 National Ambulatory Medical Care Survey published by the CDC. The annual prescription (Rx) cough market is about 26 million prescriptions per year. Of these prescriptions about 10% are written for patients experiencing refractory cough; the other 90% are written for non-refractory cough. This large patient pool — the 90% of patient with non-refractory cough — are targets for non-narcotic benzonatate.
90% of Cough Patients are Targets for the Alitair Cough Portfolio
Heightened concerns about abuse and overdose associated with narcotics, including narcotic cough medicines containing codeine and hydrocodone, have led to dramatic shifts in the cough market segmentation. Ten years ago, the Rx cough market was about evenly divided between codeine and hydrocodone based products with only a small portion held by benzonatate formulations (Tessalon Capsules and generic formulations these gel-caps). Now, the benzonatate molecule as become the leading choice for cough prescriptions. The Alitair benzonatate ion-exchange resin formulated tablet is designed to provide significant points of differentiation and preferences as compared to benzonatate gel-caps.
It is our core belief that the prescription cough market is large and underserved with significant opportunities for new non-narcotic products … particularly for oral 12-hour tablet formulations with better safety profiles and improved patient convenience.
Large commercial opportunity — We believe our prescription cough products will compete in a market valued at $3 billion at branded prices. Based on most recent data, non-narcotic prescription cough products like benzonatate have surpassed narcotic prescribing. However, we believe that some patients, up to 20%, will still need a proven narcotic option to control their cough and that a 12-hour tablet with an Abuse Deterrent formulation will gain usage and market share. We believe Alitair cough products will hold best-in-class and first-in-class points of differentiation. Alitair uniquely has a portfolio of oral tablet non-narcotic and narcotic options for physicians and patients seeking symptomatic relief from severe cough.
Strong intellectual property — Our cough portfolio is supported by multiple issued patents. The patents surround ion-exchange resin formulations for immediate release and sustained release tablets, composition of matter for benzonatate polacrilex tablets and benzonatate safety claims.
Robust market research — Data from qualitative and quantitative market research highlights the benefits of our benzonatate tablet and physician preference shares are very strong indicating wide adoption once approved. The benefits of a 12-hour non-narcotic tablet — taking one before bed and one in the morning — and a safer formulation are clear to physicians.
Potential to lower the risks narcotic cough medicine misuse and avoid messy liquid formulations — Prescribing benzonatate is the best way to avoid the risks of narcotics. However, if a narcotic prescription is needed, Alitair tablets formulations may lower the chance of abuse and misuse because of the inherent Abuse Deterrent features of an ion-exchange resin formulation. Plus, tablet formulations avoid the messy liquids (syrups and suspensions) and the chance of mis-dosing liquids when the measuring cup goes missing. They could remove several compliance to therapy issues as well.
Product Development Strategy
Alitair’s development strategy emphasizes speed, low research & development costs, and efficient regulatory and marketing strategies. Alitair has had multiple pre-IND meetings with the FDA. These meetings were used to gain valuable insights into FDA’s view of the proposed development path. As a result of these meetings, Alitair can develop its products using the 505(b)(2) route and has good guidance on the studies needed as a basis of approval. The various approved patents should provide Orange Book listing and an attractive period of exclusivity.