SMART/Script™ (SMART / Simple, Controllable, Resistant, Insoluble, Physical Trap) is a physicochemical, abuse deterrent formulation technology utilized for short or long acting acting commonly abused oral medications such as opioids and amphetamines. Formulating with SMART/Script™ allows for the the potential reduction in misuse with certain types of pharmaceuticals products. For currently marketed tablets and capsules of oral opioids such as oxycodone and morphine, products are simply crushed or chewed, and then snorted or injected using common solvents for rapid absorption and euphoria.
A product formulated with SMART/Script™ can deliver otherwise abuse-prone, orally administered immediate (IR) and controlled/extended release (CR/ER) narcotics, such as oxycodone, resistant to oral and non-oral abuse while maintaining the effectiveness of the drug per its intended use and without undesired side effects of the technology to a patient.
A SMART/Script™ formulated dosage form significantly increases the time, tools and sophistication necessary to abuse prescription drugs by oral or non-oral means using a simple and inexpensive physical/chemical component system. The technology reduces an abuser’s ability to obtain a euphoric dose of drug ‐ which results in a ‘high’ through nasal insufflation (snorting), direct injection or by crushing and swallowing a dosage form by decreasing the amount of drug released in a given time period (faster and/or non‐oral drug release = greater “high” and desirability for abuse). If the drug is intentionally or accidently chewed or otherwise physically destroyed, SMART/Script’s™ inactive ingredients (referred to as the drug TRAP) will agglomerate with and may sequester the drug matrix thereby decreasing or slowing drug diffusion and release out of the dosage form. This agglomeration is analogous to an insect (the drug) immobilized in sap (the TRAP).
The decrease in drug release from a SMART/Script™ dose is triggered by physical manipulation and does not require the addition of external fluids such as water, saline or saliva to elicit the sequestration such as in the case of using gelling agents.
Opioid abuse is a growing healthcare issue. Tampering with an an oral opioid and self-administering it nasally or intravenously results in a rapid, and potentially fatal, rise in the blood concentration of the drug. Since a rapid rate of rise in blood concentration is more likely to result in drug liking and reinforcement than a slower rise as when taken orally, there is an increase in the abuse liability of the drug which leads to increased healthcare and societal costs. Increased healthcare costs come in the form of rehabilitation and treatments, emergency room admissions, repeat physician visits and disease transmission. Overall societal costs come in the form of increased criminal justice costs associated with drug abuse, accidental death, potential homelessness and lost labor and wages.
Atlantic believes that in addition to the aforementioned healthcare costs and societal issues currently associated with opioid abuse, there will be a shift in abuse patterns to more short acting opioids. This may be accelerated due the fact that as sustained release formulations which possess abuse deterrent properties are being approved and marketed, abusers may seek out immediate release formulations of the same molecules leading to increases in abuse from current levels.
Atlantic’s lead product candidate, ATLP-02, an immediate release oxycodone, is targeted for the relief of moderate to severe pain. This product candidate has undergone extensive in vitro testing and pre-clinical development and has met its pre-endpoints for dissolution and in vitro abuse simulation testing. Based on these studies the product is expected to be beneficial in deterring abuse by oral administration (e.g. chewing, crushing), intravenous injection, buccal absorption, smoking and nasal administration. We are in the process of completing pre-clinical testing on several additional opioid candidates. Pending the clinical data from the initial trial on ATLP-02, Atlantic will develop its future plans for additional candidates using the SMART/Script™ system.
Atlantic is furthering the development for ATLP-02 and has conducted a successful pre-IND meeting with the Food and Drug Administration at the end of March 2011 for ATLP-02