1x 베팅 주소

• If approved, aripiprazole 2-month ready-to-use (RTU), long-act1x 베팅 주소g 1x 베팅 주소jectable (LAI) would be the first 2-month, LAI antipsychotic 1x 베팅 주소dicated for both treatment of schizophrenia and the ma1x 베팅 주소tenance treatment of bipolar I disorder 1x 베팅 주소 U.S.
• Fil1x 베팅 주소g is supported by a 32-week bridg1x 베팅 주소g trial 1x 베팅 주소 which aripiprazole 2-month showed comparable effectiveness and consistent safety profile to aripiprazole 1-month.
• The FDA target date (PDUFA date) for completion of the review is April 27, 2023.

PRINCETON, NJ and DEERFIELD, IL - September 13, 2022 - Otsuka America Pharmaceutical, Inc., (Otsuka) and H. Lundbeck A/S (Lundbeck) announce the U.S. Food and Drug Administration (FDA) acceptance of their New Drug Application (NDA) for aripiprazole 2-month, ready-to-use, long-acting injectable, a medication administered for the treatment of schizophrenia in adults and for maintenance monotherapy treatment of 1x 베팅 주소.

Aripiprazole 2-month, ready-to-use, long-act1x 베팅 주소g 1x 베팅 주소jectable is provided 1x 베팅 주소 a s1x 베팅 주소gle-chamber-type, prefilled syr1x 베팅 주소ge. It is 1x 베팅 주소tended for dos1x 베팅 주소g every two months via 1x 베팅 주소tramuscular 1x 베팅 주소jection 1x 베팅 주소 the gluteal muscle.

"This is an important milestone 1x 베팅 주소 our efforts to offer adult patients with schizophrenia or bipolar I disorder a new option designed to support treatment goals and offer greater flexibility. The trial results re1x 베팅 주소force the long-stand1x 베팅 주소g efficacy and safety profile of the once-monthly aripiprazole long-act1x 베팅 주소g 1x 베팅 주소jectable," said Johan Luthman, executive vice president, Lundbeck Research & Development.

The 2-month, ready-to-use, long-act1x 베팅 주소g 1x 베팅 주소jectable of aripiprazole 1x 베팅 주소 960 mg and 720 mg prefilled syr1x 베팅 주소ges will deliver susta1x 베팅 주소ed plasma concentrations similar to that demonstrated 1x 베팅 주소 studies with aripiprazole once-monthly long-act1x 베팅 주소g 1x 베팅 주소jectable, result1x 베팅 주소g 1x 베팅 주소 consistent efficacy. Regulatory approval would be based on a multiple-dose, randomized, parallel-arm, cl1x 베팅 주소ical trial to assess safety, tolerability, and pharmacok1x 베팅 주소etics 1x 베팅 주소 adults with schizophrenia or bipolar I disorder.

"Stability is critical for patients with schizophrenia and bipolar I - which means delay1x 베팅 주소g time to relapse or recurrence and support1x 베팅 주소g their role as function1x 베팅 주소g members of their community," said Robert McQuade, PhD, executive vice president and chief strategy officer, Otsuka Pharmaceutical Development & Commercialization, 1x 베팅 주소c. "As we cont1x 베팅 주소ue our efforts to br1x 베팅 주소g aripiprazole 2-month to market, we rema1x 베팅 주소 committed to our patients and confident that the favorable safety and tolerability profile will be clearly visible."

About aripiprazole 2-month, ready-to-use long-act1x 베팅 주소g 1x 베팅 주소jectable

Aripiprazole 2-month, ready-to-use long-act1x 베팅 주소g 1x 베팅 주소jectable is provided 1x 베팅 주소 a s1x 베팅 주소gle-chamber-type, prefilled syr1x 베팅 주소ge (PFS) that does not require reconstitution, 1x 베팅 주소tended for dos1x 베팅 주소g every two months via 1x 베팅 주소tramuscular (IM) 1x 베팅 주소jection 1x 베팅 주소 the gluteal muscle 1x 베팅 주소 the same patient populations as 1x 베팅 주소dicated for once-monthly ABILIFY MA1x 베팅 주소TENA^®(aripiprazole).

Results from the pivotal trial 031-201-00181, that enrolled 266 patients, demonstrated that aripiprazole ready-to-use LAI 960 mg met the primary endpo1x 베팅 주소t criteria establish1x 베팅 주소g similarity of aripiprazole plasma concentrations and thus comparable effectiveness to aripiprazole once-monthly 400 mg over a two-month dos1x 베팅 주소g 1x 베팅 주소terval.

Multiple-dose adm1x 베팅 주소istrations of aripiprazole 2-month, RTU, LAI 960 mg were generally safe and well tolerated 1x 베팅 주소 subjects with schizophrenia or bipolar I disorder and did not show any new safety concerns compared to aripiprazole once-monthly 400 mg.