Nektar Therapeutics (NASDAQ:NKTR): when success is sweet
On 19 June, Nektar Therapeutics (NASDAQ:NKTR) presented positive data from the Human Abuse Liability (HAL) study for its first-in-class investigational opioid for the treatment of chronic pain, NKTR-181, at the 2013 The College on Problems of Drug Dependence Annual Meeting. NKTR’s opioid analgesic molecule has a slow rate of entry into the brain. This slow rate of entry has been specifically designed to reduce euphoria that can result in the addiction to and abuse of current opioid analgesics. In the study data that was presented, NKTR-181was rated similar to the placebo in “feeling high” and “drug liking” scores.
Its scores for the same were statistically significantly lower on both counts in comparison to oxycodone at all the doses that had been tested. Prescription opioids are crucial for managing moderate-to-severe chronic pain. However, the misuse and abuse of these drugs have led to a severe public health crisis.
Why is HAL testing necessary?
Almost every drug that is used in the treatment of illnesses also poses certain risks. One major risk, that is generally limited to drugs that affect the central nervous system, is that the drug will be abused or misused due to the effect of these effects. These kinds of drugs are said to have the abuse liability or abuse potential. If the drugs are important from a therapeutic standpoint, they might still be allowed to be sold, however, there will be certain legal controls under various state and federal laws that they are subjected to. Over the past half a century, numerous methods to test new drugs have been developed.
All these tests determine their specific abuse liability. This helps in keeping the medical profession and the public warned about the requirement for appropriate caution while using certain drugs. These methods involve both, animal (preclinical) and human (clinical) testing.
Numerous codes and regulations that have been agreed upon by scientists as well as the lay public provide the norms for conducting research as well as testing with human volunteers. A clear statement is required to be signed by a volunteer after he/she has read the statement and understood it completely. These procedures are required to ensure the autonomy and protection of the volunteers for drug-abuse liability testing.