Late last month (March 31), San Diego-based Adamis Pharmaceuticals and partner US WorldMeds launched of ZIMHI – a 5ml naloxone injectable used in the emergency treatment of opioid overdose. “I think it’s a pretty important drug and we believe it will save lives,” said Adamis CEO Dennis Carlo.
Opioid overdose deaths topped 100,000 last year – a nearly 30% increase over the previous year – and was the leading cause of death in adults ages 18-45, according to CDC data. The growing number of deaths is mostly attributed to more widespread use of the potent opioid synthetic fentanyl.
Adamis CMO Ronald Moss said the new injector product, with its higher dose of naloxone, addresses the need for a better emergency treatment than the current nasal spray in use today.
“We saw a lot of reports by first responders that they were not able to resuscitate people without multiple doses of the nasal product,” he said.
Adamis began working on ZIMHI in 2018. The company decided to pursue a 5ml dose of naloxone for several reasons, Moss said. Pharmacokinetic modeling published in Plus-One showed that a higher dose is needed when dealing with fentanyl overdose, and the standard 4ml nasal treatment delivers half of Adamis’ injectable when accounting for absorption. Also, the 5ml dose has equal absorption to the medically approved 2ml intravenous treatment, which made FDA approval for ZIMHI an easier process.
“Plus, the higher dose showed a more rapid uptake, and when you’re talking about minutes between life and death, it makes a big difference,” Moss added.
Carlo predicts that first responders will prefer using ZIMHI over nasal products because of the reduced risk of infection from diseases like COVID-19.
“With the intramuscular dose, no matter where the person is laying on their stomach or back, it is injected into the thigh – you don’t get anywhere near the nose,” he said.
COVID Treatment in Clinic
In addition to the launch of ZIMHI, Adamis is also currently testing the drug Tempol as a treatment for inflammation caused by COVID-19.
“We think Tempol is a very important drug,” Carlo said. “It’s differentiated from the other antivirals. Tempol is a very strong antioxidant. It’s also an anti-coagulant and it’s also an anti-inflammatory drug. And currently, there’s nothing out there like that right now.”
Tempol was developed by the National Cancer Institute at the NIH as a treatment for radiation illness. Adamis licensed the drug from MatrixBio at the onset of COVID to explore its effect on severe immune reactions called cytokine storms, which are common in COVID patients.
“Much of the damage in the body is not caused by the virus but by the response to the virus,” Moss said, adding that treating the inflammation caused by COVID is an “unmet need” that is not addressed in current COVID pills developed by Merck and Pfizer that solely work to keep the virus from replicating.
Tempol recently finished its first Data Safety Monitoring Board review with positive results and will complete another in May covering 125 patients.
Adamis also completed supportive studies for Tempol. A study at the University of Texas challenging hamsters with COVID and given Tempol showed significant decreases in lung inflammation. And a Stanford University study that took immune cells from COVID patients and incubated them with Tempol, saw pro-inflammatory cytokines “in a test tube at least” were decreased when the cells saw COVID,” Moss said.
“We hope this all translates to a quicker resolution of symptoms,” he added. “We also think there may be a role for this drug to treat long-term COVID, which we’re exploring right now.”
The launch of ZIMHI and the promising studies for Tempol are some good news for the company amidst a voluntary national recall of its Symjepi epinephrine injectors last month.
Four lots of the injectors, which are manufactured by Catalent in Belgium, were found to have clogged needles that could inhibit the epinephrine from coming out.
“It was a major problem, so we began looking into it. Obviously, due to safety, we recalled the product,” Carlo said, adding that there were no reports of issues with any products used by patients. “But we recalled it anyway, just to be safe.”
Adamis expects the issue will be resolved by the end of the month and will resume production of Symjepi at that time, which Carlo hopes will reverse Adamis’ falling stock price.
“I think the stock is going down because people are saying, ‘Well they’re not selling anything right now,’” Carlo said. “We think it’s all due mainly to sales and once sales go up, I think the stock will go up.”
Carlo added that he and Adamis’ partners expect ZIMHI will do very well with sales and give the company a boost.
“We take products that are already approved and make them a little bit better,” he said. “Nasal naloxone did $400 million in sales last year and if we can get a small percent of that selling our high-dose product, we’ll be a very happy little company.”
CEO: Dennis Carlo
Headquarters: Carmel Valley
Business: Pharmaceutical company
Stock: ADMP (NASDAQ)
Revenue: $2.21 million
Notable: In the past six years, Adamis has moved three drugs through FDA approval.