De­vel­op­ing non-opi­oid pain drugs: Com­pa­nies ques­tion if FDA is rais­ing the bar

As the opi­oid epi­dem­ic rages on in the US, tak­ing the lives of more than 100,000 peo­ple in the last year alone, com­pa­nies de­vel­op­ing new non-opi­oid pain drugs are ques­tion­ing the FDA on its new draft guid­ance.

The draft in ques­tion, re­leased in Feb­ru­ary, pro­vides in­dus­try with some pa­ra­me­ters around which it can work to de­vel­op these po­ten­tial­ly less ad­dic­tive pain meds. The guid­ance ad­dress­es FDA’s cur­rent think­ing on 3 spe­cif­ic top­ics: de­vel­op­ment of non-opi­oid anal­gesics for acute pain, la­bel­ing claims and ex­pe­dit­ed pro­grams.

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