ON A MISSION

UA startup focuses on ‘forgotten victims’ of opioid addiction

By John Callahan

Neonatal opioid withdrawal syndrome (NOWS) is a condition that can occur when a pregnant woman chronically uses opioids, causing the baby to experience symptoms of opioid withdrawal such as high-pitched crying, tremors, convulsions and vomiting, and is associated with life-long neurobehavioral problems.

Since 2000, the incidence of prenatal opioid-use disorder has increased more than sevenfold in the United States.

Pediatrica Therapeutics is a pharmaceutical startup company launched in January by University of Arkansas graduate students to help what CEO Megan Reed described as some of the forgotten victims of the opioid epidemic: unborn and newborn babies.

The Pediatrica mission is gaining traction. The startup won first place and a $20,000 cash prize among graduate-level teams in the technology division of the 2023 Arkansas Governor’s Cup Collegiate Business Plan Competition, held in April.

Reed said the condition is treatable but can require a newborn to spend an average of 16 days in the neonatal intensivecare unit, with a treatment cost ranging from $22,500 to $79,900 per child. The annual financial burden of NOWS may be as high as $2.5 billion in the United States alone, accounting for some 13 percent of the $18.9 billion spent on neonatal hospital stays each year, Reed said.

“In general, you could think of Pediatrica Therapeutics as a company that’s trying to tweak or modify already FDA-approved drugs so they’re less harmful to the fetus,” said Chief Scientific Officer Julia Tobacyk. “There are a lot of people that become dependent on opioids. Sometimes, it’s because they’re prescribed painkillers after a surgery. They take it too many times, then they become dependent, and it’s very hard to quit opioids. This is a little bit counterintuitive, but to treat opioid dependence and addiction, you use another opioid.”

The two most common drugs to treat opioid dependence are methadone and buprenorphine. A patient recovering from opioid addiction might be prescribed one of these drugs to suppress cravings for more dangerous opioids like heroin or fentanyl. The dosage of these drugs can then be tapered down, avoiding the harsh symp- toms of withdrawal and allowing the patient to focus on recovery.

Unfortunately, it is also a chronic treatment, meaning that, in many cases, it never really ends. A patient may have to take methadone or buprenorphine for the rest of his or her life, much like someone with Type 1 diabetes must take insulin. As a result, even if someone has done all of the right things in trying to recover from opioid dependency, there is still more than a 50 percent chance that pregnancy could result in an infant with NOWS.

As Reed explained, NOWS is not only harmful for the child. For a woman who is already trying to recover from opioid dependence, the stress of having a baby but being unable to bond while it is in the NICU can be highly traumatic. In some cases, this trauma may lead the mother to go off treatment, which can jeopardize the longterm stability of the child’s home life.

“For a lot of the opioid-use disorder treatments that are available, there’s not really innovation,” Reed said. “These treatments have been around for decades, and people aren’t really trying to make any changes.”

Tobacyk said Pediatrica is dedicated to bringing its novel drug through the drug development pipeline to prevent neonatal opioid withdrawal syndrome.

“We’re looking at some commonly used drugs that treat opioid use disorder and how we can modify them so there’s less fetal exposure to opioids. Subsequently, that would lead to less neonatal opioid withdrawal syndrome. It would probably also decrease long-term developmental consequences that are associated with prenatal opioid exposure.

“The gold standard treatment for OUD during pregnancy is a medication called buprenorphine. Research shows that it is not BUP itself, but its harmful breakdown products contribute to NOWS. Pediatrica Therapeutics has developed a novel drug by tweaking or modifying its pharmacology, so it serves as a fetal protectant against NOWS.”

Reed and Tobacyk are Health Science Innovation and Entrepreneurship (HSIE) postdoctoral fellows at the University of Arkansas for Medical Sciences. They are joined on the Pediatrica team by Hayot Tuychiev, chief marketing officer, two-time Emmy-winning documentary filmmaker and journalism instructor at the UA in Fayetteville, and COO Veronica Garcia, former director of community engagement and inclusion at the Springdale Chamber of Commerce.

Pediatrica’s novel drug is the result of research from Tobacyk, her research mentor and postdoctoral adviser, Lisa Brents, Ph.D., as well as UAMS Professor of Pharmaceutical Sciences Peter Crooks, Ph.D. Tobacyk and Brents together filed the provisional patent application for the drug with all of the research conducted in Brents’ laboratory.

The HSIE program is designed to teach scientists to think like entrepreneurs and channel their research discoveries into commercial ventures to bring new health care products to patients. As such, Reed and Tobacyk have been required to take business classes in the Graduate Entrepreneurship Program in the UA Sam M. Walton College of Business in Fayetteville, where they have learned how to start a business under the tutelage of Sarah Gorforth, the executive director of the Office of Entrepreneurship and Innovation, and

David Hinton, PhD, vice chancellor for economic development and acting executive director of Technology Ventures.

“If not for the HSIE program, Megan and I would have never formed a company,” Tobacyk said.

The Pediatrica team has competed in other prestigious businessplan competitions and done well, but the Governor’s Cup represented its first win. It reached the finals of the Baylor New Venture Competition and Heartland Challenge, and took second at the Stu Clark New Venture Championships in Winnipeg, Canada.

The team will use part of its cash prize to cover travel costs to other competitions, including the renowned Rice Business Plan Competition in early May.

“There were about 180 applications for the Rice competition, and they selected 42,” Reed said. “It’s amazing, because our team is associated with the University of Arkansas, and we’re competing against teams from Oxford, Harvard and Johns Hopkins. It’s impressive to me, but it also makes me realize how we can do good work anywhere. And it shows that the training they give you at Fayetteville is world-class.”

In addition to winnings from business competitions, the team is also looking into obtaining Small Business Innovation Research grants and other forms of funding to help further its research.