Intended to Deter Swallowing Excess Quantities of Tablets
Niacin, an active ingredient in vitamins, cholesterol reducers and nutritional supplements, may also be included in opioid analgesic product candidates utilizing Aversion Technology. We believe that should a person swallow excess quantities of tablets utilizing Aversion Technology with niacin they will experience disliking symptoms, including intense flushing, itching, sweating and/or chills, headache and a general feeling of discomfort as a result of the increasing dose of niacin. It is expected that these niacin-induced disliking symptoms will begin approximately 10 to 15 minutes after the excess dose is swallowed and will dissipate approximately 75 to 90 minutes later. In addition, we believe it is generally recognized by physicians, nurses, and other health care providers that niacin has a well established safety profile in long term administration at doses far exceeding the amounts in each product candidate utilizing Aversion Technology with niacin. We believe the undesirable niacin effects at escalating doses will not prevent, but are expected to deter, swallowing excess quantities of product candidates utilizing Aversion Technology with niacin, although there can be no assurance in this regard. It has been known for years that niacin side effect may be mitigated if niacin is taken with food or with certain doses of non-steroidal anti-inflammatory drugs. The addition of niacin to products utilizing Aversion Technology will expose legitimate pain patients to low, safe levels of niacin without expected impact on the desired opioid analgesic effects but may cause a mild flushing in some of these pain patients.