Adamis Pharmaceuticals Updates Comparative Pharmacology Model Data Supporting the Higher 5 mg Intramuscular Dose of Naloxone in ZIMHI™Drug overdoses are the leading cause of death for those under age 50
SAN DIEGO, Dec. 01, 2021 (GLOBE NEWSWIRE) -- Adamis Pharmaceuticals (NASDAQ: ADMP) announced today that additional data in a quantitative systems pharmacology model supports the dose of naloxone hydrochloride that is included in the company’s ZIMHI™ (naloxone HCL Injection, USP) 5 mg/0.5 mL product. The model data supports the dose of naloxone in ZIMHI as being more likely to produce successful resuscitation of high concentration fentanyl overdoses. These results support the dose of naloxone in ZIMHI™ as being appropriate for more likely successful resuscitation from fentanyl overdoses, thereby saving more lives. The company recently announced that the U.S. Food and Drug Administration has approved ZIMHI for use in the treatment of opioid overdose.
Naloxone is an opioid antagonist and is generally considered the drug of choice for immediate administration for opioid overdose. It works by blocking or reversing the effects of the opioid, including extreme drowsiness, slowed breathing, or loss of consciousness. Common opioids include morphine, heroin, tramadol, oxycodone, hydrocodone and fentanyl. Fentanyl is approximately 100 times more potent than morphine.
According to statistics published by the Centers for Disease Control and Prevention (CDC), drug overdoses resulted in approximately 100,306 deaths in the United States during the 12-month period ending April 2021, which was a 29% increase over the prior 12-month period. Drug overdoses are now the leading cause of death for Americans under age 50, with more powerful synthetic opioids, like fentanyl and its analogues, responsible for the largest number of those deaths. The deaths represent a new record high.
The company previously announced the publication of an article entitled “Higher naloxone dosing in a quantitative systems pharmacology model that predicts naloxone-fentanyl competition at the opioid mu receptor level” in the peer reviewed publication “PLOS ONE”. This study was done in collaboration with Rosa & Co. LLC (www.rosaandco.com). The new data expands the previous findings to include additional doses of naloxone, comparing the dose in ZIMHI to the already approved higher intranasal (IN) dose, and higher levels of fentanyl exposure.
The previous manuscript described an opioid receptor quantitative systems pharmacology (QSP) model which was developed to predict the effects of different intramuscular (IM or the equivalent IN dose) doses of naloxone in response to different levels of fentanyl exposure (low, medium, high, and very 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 (equivalent to 4 mg IN) naloxone resulted in successful resuscitations within ten minutes, but more rapid reversal was observed with the 5 mg IM dose. However, at high levels of fentanyl exposure, the model predicted that the 2 mg IM (4 mg IN) doses of naloxone did not result in a successful reversal. In contrast, the 5 mg IM doses of naloxone (ZIMHI) successfully reversed opioid toxicity.
The new experiments examined the 4 mg IM (equivalent to 8 mg IN) dose in the model. The time to decreasing the amount of opioid (fentanyl) bound to the brain receptors to less than 50% was found to be earlier for the 5 mg IM dose (found in ZIMHI) compared to the 4 mg IM dose (8 mg IN) at high level of fentanyl exposure. At the highest fentanyl concentration tested, the 5 mg IM, but not the 4 mg IM (8 mg IN), decreased fentanyl brain receptor occupancy to less than 50%. Thus, the 5 mg IM resulted in a successful resuscitation in this model, but the 4 mg IM (8 IN) did not.
Dr. Dennis J. Carlo, President and CEO of Adamis, stated, “We believe these additional data support the need for ZIMHI’s higher IM dose of naloxone in the treatment of opioid overdoses, particularly those that involve fentanyl. The data generated predicts that ZIMHI will result in more rapid and higher levels of naloxone when compared to the other available commercial products, including the recently approved higher IN dose. This should result in more successful resuscitations and more lives saved. We believe that our partners at US WorldMeds, who are leaders in the addiction treatment area, will leverage their commercial infrastructure to successfully launch ZIMHI.”
About Adamis Pharmaceuticals
Adamis Pharmaceuticals Corporation is a specialty biopharmaceutical company primarily focused on developing and commercializing products in various therapeutic areas, including allergy, opioid overdose, respiratory and inflammatory disease. The Company’s SYMJEPI (epinephrine) Injection products are approved by the FDA for use in the emergency treatment of acute allergic reactions, including anaphylaxis. The Company’s ZIMHI (naloxone) Injection product is approved for the treatment of opioid overdose. Tempol is in development for the treatment of patients with COVID-19 and a Phase 2/3 clinical trial is underway. For additional information about Adamis Pharmaceuticals, please visit www.adamispharmaceuticals.com and follow us on Twitter and LinkedIn.
About ZIMHI™ (naloxone HCL Injection, USP) 5 mg/0.5 mL
ZIMHI is a prescription medicine used in adults and children for the treatment of an opioid emergency, such as an overdose or a possible overdose with signs of breathing problems and severe sleepiness or not being able to respond. ZIMHI is to be given right away by a caregiver and does not take the place of emergency medical care. Get emergency medical help right away after the first dose of ZIMHI, even if the person wakes up.
IMPORTANT SAFETY INFORMATION
Do not use ZIMHI if you are allergic to naloxone hydrochloride or any of the ingredients in ZIMHI.
ZIMHI is used to temporarily reverse the effects of opioid medicines. The medicine in ZIMHI has no effect in people who are not taking opioid medicines.
Use ZIMHI right away if you or your caregiver think signs or symptoms of an opioid emergency are present, even if you are not sure, because an opioid emergency can cause severe injury or death.
Family members, caregivers, or other people who may have to use ZIMHI in an opioid emergency should know where ZIMHI is stored and how to give ZIMHI before an opioid emergency happens.
Get emergency medical help right away after using the first dose of ZIMHI. Rescue breathing or CPR (cardiopulmonary resuscitation) may be given while waiting for emergency medical help.
The signs and symptoms of an opioid emergency can return within several minutes after ZIMHI is given. If this happens, give additional injections using a new ZIMHI prefilled syringe every 2 to 3 minutes and continue to closely watch the person until emergency help is received.
ZIMHI may cause serious side effects, including sudden opioid withdrawal symptoms, which may include: body aches, fever, sweating, runny nose, sneezing, goose bumps, yawning, weakness, shivering or trembling, nervousness, restlessness or irritability, diarrhea, nausea or vomiting, stomach cramping, increased blood pressure, or increased heart rate.
Other common side effects of ZIMHI include dizziness and injection site redness. In infants under 4 weeks old who have been receiving opioids regularly, sudden opioid withdrawal may be life-threatening if not treated the right way. Signs and symptoms include: seizures, crying more than usual, and increased reflexes.
These are not all of the possible side effects of ZIMHI. Call your doctor for medical advice about side effects. To report SUSPECTED ADVERSE REACTIONS, contact Adamis Pharmaceuticals Corporation at 1-858-997-2400 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
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 results of the study and additional data described in this press release and the Company’s beliefs that ZINHI will result in more rapid and higher levels of naloxone in the circulation and should result in more successful resuscitations and more lives saved; the Company’s ability to successfully commercialize the products and product candidates described in this press release, itself or through commercialization partners; future regulatory actions relating to the ZIMHI product; the Company’s beliefs concerning the benefits, enforceability, and extent of intellectual property protection afforded by patents and patent applications that it owns or has licensed and its rights under applicable license agreements, and its ability to enforce its patents and other intellectual property rights against third parties; the Company’s expectations concerning future growth; expectations and statements about the Company’s strategies, objectives, future goals and achievements; and other statements concerning our future operations, activities and financial results. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, which may cause Adamis’ actual results to be materially different from the results anticipated by such forward-looking statements. There are no assurances that use of ZIMHI will result in more rapid and higher levels of naloxone in the circulation or will result in more successful resuscitations and more lives saved, compared to other commercially available products. There can be no assurances that ZIMHI will be able to compete successfully in the market. We cannot assess the impact of each factor on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. You should not place undue reliance on any forward-looking statements. Further, any forward-looking statement speaks only as of the date on which it is made, and except as may be required by applicable law, we undertake no obligation to update or release publicly the results of any revisions to these forward-looking statements or to reflect events or circumstances arising after the date of this press release. Certain of these risks and additional risks, uncertainties, and other factors are described in greater detail in Adamis’ filings from time to time with the SEC, including its annual report on Form 10-K for the year ended December 31, 2020, and subsequent filings with the SEC, which Adamis strongly urges you to read and consider, all of which are available free of charge on the SEC's website at http://www.sec.gov.
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