The Spanish company Esteve has obtained approval from the American FDA for its new treatment, Seglentis, indicated for the treatment of acute pain in adults. The total market for this therapeutic area in the United States is between 1,000 and 1,500 million euros.
The drug is Esteve’s first own research product to be marketed across the Atlantic. The Spanish company will rely on the pharmaceutical company Kowa to market the drug in the United States. In addition to the royalties the drug provides through its sales, the company will also receive regulatory milestone payments. The agreement, according to the company agreed to this medium, is long-term.
This move comes as the company is also working on marketing the drug in Europe. Esteve is pending to receive the approval of the European Medicines Agency, but also accelerates with some countries to try to shorten the deadlines. Negotiations with Spain, Italy and Portugal are currently open.
Seglentis is an innovative medicine, the first of its kind, composed of a cocrystalline form of celecoxib (anti-inflammatory) and tramadol (pain reliever). The company stresses that the drug offers a new acute pain treatment option aligned with multimodal analgesia, currently considered the standard of care for pain control.
Staffan Schüberg, CEO of the Spanish pharmaceutical company, declared that they are “very proud of this achievement, as it is recognition of our daily efforts to meet the needs of patients and address the current challenges of treating acute pain.”