MAPS plans to seek approval of MDMA-assisted therapy this year after second positive PhIII trial

MAPS Pub­lic Ben­e­fit Cor­po­ra­tion is tout­ing an­oth­er set of promis­ing Phase III re­sults in­ves­ti­gat­ing its MD­MA-as­sist­ed ther­a­py for post-trau­mat­ic stress dis­or­der (PTSD), with the tri­al hit­ting pri­ma­ry and sec­ondary end­points as the or­ga­ni­za­tion pre­pares for an NDA fil­ing this year.

The tri­al, MAPP2, is the sec­ond Phase III to con­firm pos­i­tive re­sults in pa­tients with PTSD.

Most of the par­tic­i­pants had a “sig­nif­i­cant re­duc­tion” in symp­toms of PTSD ver­sus those on place­bo who al­so re­ceived ther­a­py, earn­ing a p-val­ue of 0.001, with 86.5% ex­pe­ri­enc­ing a clin­i­cal­ly mean­ing­ful im­prove­ment at 18 weeks com­pared to 69.0% in the place­bo group.

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