Atlantic Pharmaceuticals Announces Successful Pre-IND Meeting for Abuse-Deterrent Hydrocodone
Atlantic Pharmaceuticals, Inc.recently announced it has completed a successful Pre-Investigational New Drug Meeting with the FDA on a single-component, immediate -release, abuse-deterrent hydrocodone (ATLP-03). Currently, all marketed prescription products containing hydrocodone also contain additional APIs that may be unnecessary or detrimental to the patients taking those products. Hydrocodone is also considered a drug with a high abuse potential, and current combination products can be crushed and administered nasally, injected, or chewed in order to obtain a rapid euphoria. In contrast to the currently marketed hydrocodone combination products, ATLP-03 does not contain any additional active ingredients and is formulated with Atlantic’s patented abuse-deterrent SMART/Script system. ATLP-03 may be pursued under the FDA’s abbreviated 505(b)2 NDA program in accordance with the outcome of the Pre-IND meeting with the FDA.
Atlantic’s abuse deterrent platform, SMART/Script, has been designed to resist attempts to easily extract a drug from an oral dosage form and has the ability to sequester and reduce the drug release from a dosage that has been subjected to a variety of physical methods of tampering and abuse. The technology can be applied to immediate as well as sustained-release drug candidates.
SMART/Script (SMART, Simple, controllable, resistant, insoluble, physical trap), a novel, patented drug delivery technology, was designed to prevent easy drug extraction and to deter the abuse of medications via known routes of abuse or misuse, including chewing, snorting, and injecting. Orally delivered prescription pharmaceuticals, such as narcotics, are frequently subjected to abuse and misuse via chewing and swallowing or crushing and either snorting or injecting the resultant powder in order to obtain a fast euphoria. A product formulated with SMART/Script, however, resists extraction in water or alcohol and can be used with a broad range of opioids and non-opioids in immediate or extended-release forms. SMART/Script is also unique among competitive technologies in that physical manipulation, such as chewing or crushing, may result in reducing the release of the drug as opposed to increasing it.
Atlantic Pharmaceuticals is a specialty pharmaceutical company using its patented technology to produce novel therapeutics that resist attempts at tampering and may be useful to reduce abuse of certain prescription drugs. For more information, visit atlanticpharma.com.
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