Stockholm, Sweden, Moberg Pharma AB (publ) (STO: MOB) today announced that the Swedish Medical Products Agency (MPA) has granted national approval for MOB-015, a novel, orally disintegrating tablet for the treatment of irritable bowel syndrome with constipation (IBS-C).
MOB-015 is a first-in-class, peripherally-acting mu-opioid receptor agonist that is specifically designed to treat the constipation symptoms of IBS-C. It is the first and only orally-disintegrating tablet for the treatment of IBS-C, and it is also the first and only mu-opioid receptor agonist that is not subject to abuse or dependence.
The approval of MOB-015 is based on the results of Phase III clinical trial in which MOB-015 was shown to be significantly more effective than a placebo in relieving constipation symptoms in patients with IBS-C. MOB-015 was also well-tolerated, with a safety profile that was comparable to placebo.
“We are delighted to receive national approval for MOB-015 in Sweden,” said Per Moberg, CEO of Moberg Pharma. “This is a significant milestone for Moberg Pharma, and we are excited to make MOB-015 available to patients in Sweden who are suffering from the constipation symptoms of IBS-C.”
MOB-015 is expected to be launched in Sweden in the second quarter of 2023. The company is also planning to submit MOB-015 for regulatory approval in other countries.
About Moberg Pharma
Moberg Pharma is a Swedish pharmaceutical company focused on the development and commercialization of novel treatments for gastrointestinal disorders. The company’s lead product candidate, MOB-015, is a novel, orally disintegrating tablet for the treatment of irritable bowel syndrome with constipation (IBS-C). MOB-015 has been granted national approval in Sweden, and the company is planning to submit MOB-015 for regulatory approval in other countries.
For more information, please visit www.mobergpharma.com.