SDN - 021
SDN - 021 is an abuse deterrent formulation of one of the most prescribed opioid analgesics. The most prevalent route of abuse for SDN - 021 is oral ingestion of multiple pills. SPARC has developed abuse deterrent technology that has ability to deter abuse by oral ingestion of multiple pills.
SDN - 021 delivers clinically effective dose when the patient ingests prescribed dose. However, upon ingestion of multiple pills; the technology reduces and delays the release of drug. Thus, it is expected that the abusers may not experience the euphoria or “High” they seek.
The results of pilot pharmacokinetic evaluation in healthy volunteers support the proof of concept of oral multiple pill abuse deterrence. It was observed that escalating doses of SDN - 021 resulted in less than proportional escalations in plasma exposures. The formulation of SDN - 021 was also able to achieve delayed Tmax potentially preventing the abuser from getting the desired “quick high”.
SPARC completed pilot Human Abuse Liability (HAL) study in oral multi-pill abusers. The study demonstrated that the Cmax is blunted when multiple pills of SPARC formulation are ingested versus the reference product. SPARC plans to out-license the program and would develop it further in collaboration with partner.