Sunshine Biopharma Inc. (NASDAQ:SBFM) announced that its wholly owned subsidiary, Nora Pharma Inc., has received approval from Health Canada for the commercialization of domperidone, a prescription medication used to relieve nausea and vomiting and enhance gastrointestinal motility. The approval represents a significant regulatory milestone for the pharmaceutical company focused on innovative and affordable healthcare solutions.
Therapeutic Application and Mechanism
Domperidone is particularly valuable for managing chemotherapy-induced nausea and vomiting, especially when patients cannot tolerate other antiemetics that may cause extrapyramidal side effects. The medication works by blocking dopamine receptors in the gut, helping reduce nausea and improve gastric motility. This mechanism of action makes it an important treatment option for cancer patients undergoing chemotherapy who experience severe gastrointestinal side effects.
Market Opportunity and Financial Projections
The approval opens access to a substantial market opportunity. According to Cognitive Market Research data cited in the announcement, global sales of domperidone are projected to reach $1.36 billion by the end of 2025. North America holds approximately 39% of the global market share, with the regional market growing from $440 million in 2021 to $533 million in 2025.
The North American domperidone market is expected to reach $781 million by 2033, representing a compound annual growth rate (CAGR) of 4.89%. Within North America, the market share distribution for 2025 is projected as follows: United States (73.7%), Canada (17.0%), and Mexico (9.30%).
Strategic Portfolio Expansion
"We are proud of Nora Pharma's continued progress in bringing essential medications to market," said Dr. Steve Slilaty, CEO of Sunshine Biopharma. "The approval of domperidone not only enhances our growing generics portfolio but also reinforces our commitment to improving patient access to effective treatments. Domperidone is widely prescribed for the management of gastrointestinal disorders and is recognized for its efficacy and safety profile."
The domperidone approval marks another milestone in Sunshine Biopharma's strategic expansion into the generic pharmaceuticals market. The company currently has 76 generic prescription drugs available in Canada, with more than 12 additional drugs scheduled for launch in 2026.
Market Response and Trading Activity
The announcement generated significant market interest, with trading volume in SBFM stock surging more than 1,600% to nearly 10 million shares traded following the news. This dramatic increase in trading activity reflects investor recognition of the regulatory milestone's potential impact on the company's commercial prospects.
Broader Development Pipeline
Beyond its generic drug portfolio, Sunshine Biopharma is conducting a proprietary drug development program that includes K1.1 mRNA, an mRNA-Lipid Nanoparticle targeted for liver cancer, and PLpro protease inhibitor, a small molecule for treatment of SARS coronavirus infections. The company also has NIOPEG®, a biosimilar targeting the same therapeutic category as Neulasta®, a multibillion-dollar oncology drug.
The Health Canada approval for domperidone strengthens Sunshine Biopharma's position in the Canadian pharmaceutical market and provides a foundation for continued growth in the generic drug sector. With domperidone's established efficacy and safety profile in treating gastrointestinal disorders, Nora Pharma is positioned to serve healthcare providers and patients across Canada with this essential medication.
