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 has initiated a pilot Human Abuse Liability study to evaluate the drug liking Emax as the primary end point between SDN - 021 and an active comparator which is non abuse deterrent. The topline results are expected by Q3 FY19.
We are planning to initiate Phase 3 clinical study to demonstrate efficacy in Q3 FY19, post FDA concurrence on the study design. Meanwhile, we were working on consolidating the development work for SDN - 021 by carrying out preliminary Category 1 studies to determine the vulnerability of the formulation. The studies demonstrate SDN - 021’s potential to resist commonly employed tampering techniques, which is a function of the chemistry based deterrence mechanism as well as the presence of an aversive agent in the formulation. Pivotal Category 1 study is targeted to commence in Q1 FY20.