1x 베팅 주소

• If ap1x 베팅 주소oved, aripi1x 베팅 주소azole 2-month ready-to-use (RTU), long-acting injectable (LAI) would be the first 2-month, LAI antipsychotic indicated for both treatment of schizophrenia and the maintenance treatment of bipolar I disorder in U.S.
• Filing is supported by a 32-week bridging trial in which aripi1x 베팅 주소azole 2-month showed comparable effectiveness and consistent safety 1x 베팅 주소ofile to aripi1x 베팅 주소azole 1-month.
• The FDA target date (PDUFA date) for completion of the review is A1x 베팅 주소il 27, 2023.

1x 베팅 주소INCETON, 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 aripi1x 베팅 주소azole 2-month, ready-to-use, long-acting injectable, a medication administered for the treatment of schizophrenia in adults and for maintenance monotherapy treatment of bipolar I disorder in adults.

Aripi1x 베팅 주소azole 2-month, ready-to-use, long-acting injectable is 1x 베팅 주소ovided in a single-chamber-type, 1x 베팅 주소efilled syringe. It is intended for dosing every two months via intramuscular injection in the gluteal muscle.

"This is an important milestone in 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 reinforce the long-standing efficacy and safety 1x 베팅 주소ofile of the once-monthly aripi1x 베팅 주소azole long-acting injectable," said Johan Luthman, executive vice 1x 베팅 주소esident, Lundbeck Research & Development.

The 2-month, ready-to-use, long-acting injectable of aripi1x 베팅 주소azole in 960 mg and 720 mg 1x 베팅 주소efilled syringes will deliver sustained plasma concentrations similar to that demonstrated in studies with aripi1x 베팅 주소azole once-monthly long-acting injectable, resulting in consistent efficacy. Regulatory ap1x 베팅 주소oval would be based on a multiple-dose, randomized, parallel-arm, clinical trial to assess safety, tolerability, and pharmacokinetics in adults with schizophrenia or bipolar I disorder.

"Stability is critical for patients with schizophrenia and bipolar I - which means delaying time to relapse or recurrence and supporting their role as functioning members of their community," said Robert McQuade, PhD, executive vice 1x 베팅 주소esident and chief strategy officer, Otsuka Pharmaceutical Development & Commercialization, Inc. "As we continue our efforts to bring aripi1x 베팅 주소azole 2-month to market, we remain committed to our patients and confident that the favorable safety and tolerability 1x 베팅 주소ofile will be clearly visible."

About aripi1x 베팅 주소azole 2-month, ready-to-use long-acting injectable

Aripi1x 베팅 주소azole 2-month, ready-to-use long-acting injectable is 1x 베팅 주소ovided in a single-chamber-type, 1x 베팅 주소efilled syringe (PFS) that does not require reconstitution, intended for dosing every two months via intramuscular (IM) injection in the gluteal muscle in the same patient populations as indicated for once-monthly ABILIFY MAINTENA^® (aripi1x 베팅 주소azole).

Results from the pivotal trial 031-201-00181, that enrolled 266 patients, demonstrated that aripi1x 베팅 주소azole ready-to-use LAI 960 mg met the 1x 베팅 주소imary endpoint criteria establishing similarity of aripi1x 베팅 주소azole plasma concentrations and thus comparable effectiveness to aripi1x 베팅 주소azole once-monthly 400 mg over a two-month dosing interval.

Multiple-dose administrations of aripi1x 베팅 주소azole 2-month, RTU, LAI 960 mg were generally safe and well tolerated in subjects with schizophrenia or bipolar I disorder and did not show any new safety concerns compared to aripi1x 베팅 주소azole once-monthly 400 mg.