dm+d

Unassigned

New Medicines

SeglentisAcute moderate-to-severe pain

Information

Seglentis
New formulation
Esteve
Esteve

Development and Regulatory status

None
Pre-registration (Filed)
Approved (Licensed)
Oct 21Approved in US; Seglentis will be commercialised in the US by KOWA Pharmaceuticals [8].
Feb 21Esteve say celecoxib+tramadol is still under review by the FDA in the US. They have also submitted a dossier for marketing authorisation to the Spanish medicines agency (AEMPS), Italian medicines agency (AIFA) and Portuguese medicines agency (Infarmed), through a decentralised process in which Spain acts as a reference member State [7].
Jul 19FDA receives the NDA for E-58425 from Esteve [5].
Dec 18Napp no longer plans to develop this for the UK after second pivotal study failed to achieve its primary end point [6].

Category

Fixed dose combination of anti-inflammatory drug celecoxib that inhibits cyclooxygenase 2 plus tramadol, a centrally acting weak synthetic μ-opioid receptor agonist and to a lesser extent δ- and κ-opioid receptors agonist.
A survey of 975 people in the UK reported that 21% experienced pain every day or on most days. 67% had visited their GP or a walk-in centre, requesting advice about pain relief [1].
Acute moderate-to-severe pain
Oral

Trial or other data

Jun 18STARDOM2 trial completed 29th June 18, final recruitment 1138 patients [4].
Dec 17PIII STARDOM1 has complete recruitment; STARDOM2 is still recruiting [3].
Apr 17PIII STARDOM2 trial to demonstrate the safety and efficacy of celecoxib/tramadol, in the treatment of acute pain following abdominal hysterectomy surgery under general anaesthesia starts (NCT03062644). Efficacy will be assessed by establishing superiority of celecoxib/tramadol over placebo and non-inferiority as compared with tramadol, followed by superiority over tramadol based on the sum of pain intensity differences over a period of 0-4 hours. The trial will enrol approximately 1,100 female patients in Eastern & Western Europe, North America and Asia. Collection of primary outcome data due to complete Jun 18 [2,3].
Dec 16PIII STARDOM1 trial to demonstrate the efficacy and safety of celecoxib/tramadol over-encapsulated tablet in the treatment of patient with acute moderate to severe pain after the extraction of at least two third molars requiring bone removal starts (NCT02982161). The study is enrolling approximately 765 patients in Hungary, Canada, France, Germany, Italy, Japan, Poland and Spain. Collection of primary outcome data due to complete Feb 18 [2,3].