Naloxone is an opioid antagonist used to treat narcotic overdoses. Naloxone works by reversing the detrimental effects of the opioid, including slowed breathing, brain dysfunction, loss of consciousness and death. Common opioids include morphine, heroin, tramadol, oxycodone, hydrocodone and fentanyl. Rapid resuscitation of an opioid overdose with naloxone, an opioid antagonist, is critical as opioid induced toxicity results in rapid death, i.e., delaying adequate resuscitation can result in death. Accordingly, the current approved naloxone doses (2 mg intramuscular (IM) and 4 mg intranasal (IN)), since they both give similar systemic exposure levels, might very well not be sufficient to reverse high doses of fentanyl. Fentanyl, a synthetic opioid, is considered 50 to 100 times more potent than morphine. According to the
The manuscript describes an opioid receptor quantitative systems pharmacology (QSP) model which was developed to predict the effects of different IM doses of naloxone ( 2 mg, 5 mg, and 10 mg) in response to different levels of fentanyl exposure (low, medium, and high). The model defined a successful reversal as lowering the amount of opioid bound to the brain receptors to less than 50% within 10 minutes. For the lowest and middle levels of fentanyl exposure, the model predicted that the 2 mg IM naloxone resulted in successful resuscitations within ten minutes, but more rapid reversal was observed with the 5 and 10 mg doses. However, at the highest level of naloxone exposure, the model predicted that the 2 mg IM (and 4 mg IN) doses of naloxone did not result in a successful reversal. In contrast, the 5 and 10 mg doses of naloxone successfully reversed opioid toxicity.
Adamis Forward Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include those that express plans, anticipation, intent, contingencies, goals, targets or future development and/or otherwise are not statements of historical fact. These statements relate to future events or future results of operations, including, but not limited to the following statements: the company’s beliefs concerning the timing and outcome of the FDA’s review of the company’s New Drug Application (NDA) relating to its ZIMHI™ (naloxone) Injection product candidate; the data and interpretation of the data from the company’s studies pertaining to the ZIMHI product candidate; the company’s ability to commercialize its product and product candidates, itself or through commercialization partners; the company’s beliefs concerning the ability of its products and product candidates to compete successfully in the market; the company’s beliefs concerning the safety and effectiveness of ZIMHI and its other products and product candidates; and other statements concerning our future operations and activities. Such forward-looking statements include those that express plans, anticipation, intent, contingencies, goals, targets or future development and/or otherwise are not statements of historical fact. These statements are only predictions, are not guarantees, involve known and unknown risks, uncertainties and other factors, and concern matters that could subsequently differ materially from those described in this press release, which may cause Adamis' actual results to be materially different from those contemplated by these forward-looking statements. There can be no assurances regarding the timing or the outcome of the FDA’s review process concerning the company’s NDA relating to ZIMHI. There can be no assurances that the FDA will agree with our interpretation of study data, will approve our NDA relating to our naloxone product candidate or will give final approval to our proposed brand name for the product, concerning the timing of any such approval, that the product will be commercially successful if approved and introduced, or concerning the outcome of any discussions with third parties concerning commercialization of the product. In addition, forward-looking statements concerning our anticipated future activities assume that we are able to obtain sufficient funding to support such activities and continue our operations and planned activities. As discussed in our filings with the
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Source: Adamis Pharmaceuticals Corporation