News Release – Uppsala, Sweden, September 29, 2023

The year of 2023 marks 10 years on the US Pharma market for Orexo. In September 2013, after conscientious preparations and an FDA approval, ZUBSOLV®, became available for patients across the US. A big achievement and the start of a journey that is making a difference to the people whose lives are affected by the US opioid epidemic. In this interview, Robert DeLuca, President of Orexo US Inc., reflects on these exciting years and how he and his team are committed to tackling the opioid crisis from broad and holistic perspective.

Robert, you have led Orexo´s US commercial business since the start, 10 years ago. What do you enjoy most?

Imagine a job where you go to work and build a business in which you contribute to solving an epidemic that’s devastating your country. It’s incredibly rewarding and I’m proud of what we do, the people we work with and our results.

This is a privileged journey for me, to be able to fight the opioid epidemic and work shoulder to shoulder with so many amazing colleagues in the US and in Uppsala, Sweden. I’ve been leading Orexo´s US subsidiary as President since 2013. It’s the pinnacle of a career commercializing dozens of pharmaceuticals across the US and internationally. ZUBSOLV® is by far the most rewarding. We have a solution to an epidemic that’s devastating patients, families, communities, and economies at local and national levels. 

I love to get out in the community when I can and talk to physicians, healthcare providers and occasionally patients. It’s refreshing and keeps you grounded.

I´ll never forget a day not long after I started at Orexo when I was out in the field with one of our reps and a patient came up to me in the doctor’s office and asked, “Are you ZUBSOLV®?”. When I said that I was, she said, “My husband let me back in the house.” I’ll never forget those words, or the look on her face. It really brought it home to me that this is the difference we’re making to people’s lives every day.  

What are your responsibilities and what are you most proud of?

The primary objective of my role is to manage the US commercial operation in a complaint way and ensure it is successful, and I am very proud of our achievements with ZUBSOLV®. For over a decade we’ve been helping thousands of patients every day to overcome their addiction and, despite the unique market dynamics, ZUBSOLV® has shown real resilience, supported by Orexo’s strong brand, robust market access and field team. Since its launch, ZUBSOLV® has generated SEK 4.8 million in net revenues, making it an important cash generator for the company, and thanks to ZUBSOLV® we’re investing in new and exciting products.

Navigating the wider political and economic landscape is also a key part of my role. I liaise with policy makers at the state and federal levels, together with many of my colleagues at Orexo, to advocate for patients and physicians and ensure we’re directly involved with the areas that are important for the company. Right now, I’m working with the state attorneys general to help them understand the value of Medication Assisted Treatment (MAT) and the significant need to funnel the Opioid Abatement Funds into treatment. The goal is to help reduce the burden of the opioid epidemic in communities across the US and pay for treatment for all those who need it.[i] Our mission at Orexo is to advocate for the right opportunities for people suffering with opioid use disorder to sustain recovery. It’s true that the market is dynamic, but by building relationships with key decision-makers, insurers, and payers, we’re continuing to execute our strategy and make a difference to society.

What makes ZUBSOLV® successful?

ZUBSOLV® was developed by our research and development team in Uppsala, Sweden, with the patient in mind. It has specific benefits for patients because it tastes better and dissolves faster than the generic formulations. Physicians get 6 doses, which gives them the flexibility to titrate just the right amount to stabilize patients and set them up for a successful recovery journey. Patients also benefit from the reassurance that their repeat prescriptions will be with the same product. We always keep the patient at the center of what we’re trying to do with ZUBSOLV®.

While ZUBSOLV® is successful, we also know there’s more work to do. The US opioid crisis has been in epidemic proportions since the late 1990s, when we saw an evolution from pain medication to heroin and more recently to synthetic illicitly manufactured fentanyl. The numbers of people dying from overdoses was over 100,000 in 2022, with around 80,000 of those deaths attributed to opioids.[ii] It was significantly less when we first started out and we know that the cartels are driving the influx of fentanyl to the US. Right now, it’s rare to find a community in the US that isn’t experiencing problems with opioids.

Orexo is about to tackle the opioid crisis from a broader perspective. Could you explain more?

I’m excited to be putting together a strategy to broaden our portfolio by bringing three more products to the US market. The first is OX124, Orexo’s pioneering rescue medication that’s based on the innovative amorphOX® nasal powder technology developed in-house by the R&D team in Uppsala.[iii] We expect OX124 to be so powerful that it’s more capable than current lower dose alternatives of reversing opioid overdoses caused by even the most potent drugs, including fentanyl. We recently filed OX124 with the FDA and we’re very excited about bringing this unique formulation to the market. In addition, we have nalmefene (OX125) in our pipeline, which is also based on amorphOX® and is being formulated for rapid and long-lasting opioid overdose reversal.[iv] We believe these products have the potential to revolutionize the recovery market and further establish Orexo as the opioid use disorder and rescue company in the US.

Contributing to saving a person’s life is a great privilege. It gives them an opportunity to begin their recovery journey, and we know that patients have much better health outcomes if they receive holistic treatments that combine MAT with therapy. Sadly, it isn’t always possible for patients to get access to high quality therapy, so we’ve developed MODIA®, an evidence-based digital support program. MODIA® educates the patient about the disease, teaches proven cognitive behavioral therapeutic techniques and monitors patient progress on opioid recovery and other important aspects of their journey to a healthy life, such as depression. I’m incredibly proud that we’re bringing this to the market in parallel with our pharmaceuticals.[v] MODIA® has been thoughtfully designed to give patients a counselling option that overcomes treatment barriers such as living in a remote area.

What’s your vision for the next five years for Orexo in the US?

I’m looking forward to successfully commercializing this broader portfolio of products in the US, in partnership with our skilled and dedicated team on both sides of the Atlantic. Careful investment will drive Orexo to new and even higher levels of success and that translates into better outcomes for more patients. It’s a noble effort and something we strive to be better at each day. It’s our responsibility to be successful so we can help stem this epidemic and put it back on the decline.

A strong Orexo is good for the US society. We’re out on the frontlines every day making sure patients get the treatments they need. My mission is to grow Orexo so we can sell more products in a compliant way and ensure they reach the patients who need them. I take that mission very seriously. It makes me proud to lead the US organization every day. I have been able to be in this role for ten years now and be successful because of the wonderful team we have in the US and Sweden. And it all goes back to that one patient who said, “My husband let me back in the house.”

Written by Georgina Hoy