Elite Pharmaceuticals Inc (ELTP)

[no2koolaid]

No, this is the factual reality, Elite is at the right point in market development of ADFs...

According to the NIH, Factors such as increasing palliative care facilities, reformed regulations for prescription of opioids, and extensive focus of generic manufacturers towards Abuse-Deterrent Formulation (ADF) are expected to drive the growth of the opioids market in North America and Europe. However, ADFs are still in their nascent stage of development and there is limited commercialization. Accordingly, ADFs must be in the market in order to determine effectiveness and make improvements where needed. The current practice of limited and incremental regulatory adoption limits the willingness of manufacturers to fund research for comprehensive ADF development. With broader regulatory support and as new ADFs increase market share, manufacturers will have the economic incentives needed to research and develop next-generation abuse-deterrent technologies.

Although pharmaceutical manufacturers have taken steps to create ADFs, regulatory uncertainty has slowed adoption in the market. Greater regulatory clarity and incentives are critical to expediting the development and use of ADFs for controlled substances commonly subject to abuse.