Zimhi (naloxone injection) / DMK Pharma, US WorldMeds - LARVOL DELTA

Nalmefene nasal spray (Opvee) for reversal of opioid overdose. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Addiction (Opioid and Alcohol) • CNS Disorders • Substance Abuse

Drugs for opioid use disorder. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Addiction (Opioid and Alcohol) • CNS Disorders • Substance Abuse

Nalmefene returns for reversal of opioid overdose. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Addiction (Opioid and Alcohol) • CNS Disorders

Zimhi - a higher-dose injectable naloxone for opioid overdose. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Addiction (Opioid and Alcohol) • CNS Disorders

"$ADMP US WorldMeds and Adamis Pharmaceuticals Announce U.S. Launch of ZIMHI™ Naloxone Product https://t.co/Yf8GJ8oqQA" (@stock_titan)

Launch US

New Naloxone Concentration Treats Opioid Overdose. (PubMed, Am J Nurs) - "Zimhi is a single-dose prefilled syringe containing 5 mg/0.5 mL of naloxone. Zimhi is administered subcutaneously or intramuscularly.Nurses should educate patients receiving opioids and their families on how to use Zimhi or other prescribed naloxone products."

Journal • Addiction (Opioid and Alcohol) • CNS Disorders

"$ADMP Adamis Pharmaceuticals Updates Comparative Pharmacology Model Data Supporting the Higher 5 mg Intramuscular Dose of Naloxone in ZIMHI™ https://t.co/vq86HHMBIQ" (@stock_titan)

"$ADMP Adamis Receives FDA Approval for ZIMHI https://t.co/HWw1Rmj54e #fdaapproval" (@stock_titan)

FDA event

"$ADMP Adamis Provides Update on ZIMHI™ https://t.co/0yswUdWyNG" (@stock_titan)

"$ADMP Adamis Pharmaceuticals Provides an Update on ZIMHI™ https://t.co/P1QMbHZMmy" (@stock_titan)

"$ADMP Adamis Pharmaceuticals Describes Planned Response to ZIMHI Complete Response Letter https://t.co/PYmWhJSL69" (@stock_titan)

Clinical • FDA event

"ZIMHI will never get approved. ADMP is roadkill and will be out of business in 6 months imho." (@JosephRamelli)

"Penny stock player Adamis gets another CRL for high-dose naloxone as shares crater https://t.co/T07prW5RBl" (@endpts)

"$ADMP Resubmits ZIMHI NDA" (@BioStocks)

NDA

Adamis Pharmaceuticals announces 2019 financial results and business update (GlobeNewswire) - "On November 22, 2019, the company received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the company’s New Drug Application (NDA) relating to its ZIMHI high-dose naloxone injection product for the treatment of opioid overdose....The company believes it can generate the additional data, and assuming successful testing, resubmit the NDA in the second quarter of 2020."

NDA

The Effects of Intramuscular Naloxone Dose on Mu Receptor Displacement of Carfentanil in Rhesus Monkeys. (PubMed, Molecules) - "However, higher mu receptor occupancy (RO) may be required to treat overdoses due to more potent synthetic opioids such as fentanyl and carfentanil that have entered the illicit drug market recently. To address this need, a higher dose of NLX has been investigated in a 5 mg IM formulation called ZIMHI but, while the effects of intravenous (IV) and IN administration of NLX on the opioid mu receptor occupancy (RO) have been studied, comparatively little is known about RO for IM administration of NLX...Plasma levels were 4.6 ng/mL, 16.8 ng/mL, and 43.4 ng/mL for the three IM doses, and a significant correlation between percent RO and plasma NLX level was observed (r = 0.80). These results suggest that higher doses of IM NLX result in higher mu RO and could be useful in combating overdoses resulting from potent synthetic opioids."

Journal

"çoook yorgunum, beni bekleme kaptan, seyir defterini başkası yazsın... #nazimhikmet @TheCemKaraca @__nazimhikmet__ #ALS #ALShastalıgı #nurown @alsadvocacy @alsassociation @alsmnhturkiye" (@KEMALETDIN)

Adamis Pharmaceuticals provides an update on Zimhi (GlobeNewswire) - "Adamis Pharmaceuticals Corporation...today provided an update on the ZIMHI™ New Drug Application (NDA) resubmission process....The company has provided responses to the comments included in the CRL and submitted these answers to the FDA this week....The company requested a Type A meeting with the agency and is currently waiting for the FDA to respond to this request. The next update from the company on the ZIMHI NDA resubmission process will be sometime after the FDA meeting occurs. At that time, the company would expect to have more information regarding the timeline for the full resubmission of the NDA back to the FDA."

FDA event • NDA

Adamis Pharmaceuticals Announces Publication of Comparative Pharmacokinetics of Community Use Naloxone Formulations (GlobeNewswire, Adamis Pharmaceuticals Corporation) - "Adamis Pharmaceuticals Corporation...announced today that an article entitled 'Comparative Pharmacokinetic Analysis of Community Use Naloxone Formulations for Acute Treatment of Opioid Overdose' was accepted for publication in the peer reviewed Journal of Addiction Research and Adolescent Behavior...The article compares the pharmacokinetics of two community naloxone formulations (2mg intramuscular (IM) and NARCAN® 4mg intranasal (IN)) to Adamis’ investigational drug ZIMHI (5mg IM) in healthy subjects. By comparison, the naloxone levels associated with ZIMHI are higher with more rapid absorption."

PK/PD data

Adamis Pharmaceuticals receives a complete response letter from the FDA regarding Zimhi (GlobeNewswire) - "Adamis Pharmaceuticals Corporation...today announced that after the close of U.S. markets on November 22nd, it received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for Adamis’ ZIMHI™ high-dose naloxone injection product for the treatment of opioid overdose. The CRL stated that the FDA determined it cannot approve the NDA in its present form and provided recommendations needed for resubmission....The questions raised by the FDA related generally to Chemistry, Manufacturing and Controls (CMC). The plan is to expand on the CMC testing...'We will take the Agency’s suggestion and request a meeting as soon as reasonably possible to discuss our plan to resubmit the NDA.' "

NDA

"$ADMP has not received any response from FDA on ZIMHI NDA. https://t.co/qAlxKCS8Ic" (@BioStocks)

NDA

"@SteveHahnMD when will we see a Zimhi approval. #admp @FDA_Drug_Info" (@BrownJakota)

Adamis Pharmaceuticals Announces Third Quarter 2019 Financial Results and Business Update (GlobeNewswire, Adamis Pharmaceuticals Corporation) - "The company believes that if approved, ZIMHI could be an important part of the solution....of opioid overdose. The company believes that discussions with potential partners for ZIMHI have sufficiently progressed and that while no assurances are possible, the company expects to be able to announce a commercial partner soon after receiving clearance from the FDA."

Licensing / partnership • NDA

Adamis Pharmaceuticals Provides Regulatory Update for Its Higher Dose Naloxone Pre-Filled Syringe (GlobeNewswire, Adamis Pharmaceuticals Corporation) - "Adamis Pharmaceuticals Corporation...today announced that as of the close of business today, Adamis has not received any notice of action from the U.S. Food and Drug Administration ('FDA') on the company’s New Drug Application relating to its ZIMHI™ high-dose naloxone injection product for the treatment of opioid overdose....Adamis intends to make an announcement relating to FDA action concerning the NDA after it receives a notice of action or similar communication from the agency."

NDA

Adamis shares fall as FDA issues CRL for its high-dose naloxone candidate (Bioworld) - "Shares of San Diego-based Adamis Pharmaceuticals Corp....fell 51% to close Monday at 62 cents after the FDA issued a complete response letter regarding its high-dose naloxone injection candidate, Zimhi, for the treatment of opioid overdose. The agency raised questions about chemistry, manufacturing and controls (CMC), but not the candidate's safety or efficacy, the company said."

NDA • Stock price