Alkermes's Aristada in the Wake of FDA Approval
The FDA (Food and Drug Administration) approved Aristada (Aripiprazole Lauroxil) partly on account of the drug’s clinical trials, which proved that patients using the treatment saw reductions in the symptoms of schizophrenia. In addition to its clear efficacy and ease of use (in terms of the range of dosages and dosing intervals), Aristada’s ready-to-use product format was also instrumental in the FDA’s decision to approve the drug.
The above diagram shows that the results of phase 3 study of Aristada, which was conducted on 623 schizophrenia patients. Patients taking dosages of 441 mg and 882 mg—both delivered on a monthly basis—saw significant reductions from baseline PANSS (positive and negative syndrome scale) scores at the end of week 12, compared to the results obtained by delivering placebo. PANSS is a scale used to measure the severity of schizophrenia symptoms.
ClinicalTrials.gov defines a placebo as “a substance that does not contain active ingredients and is made to be physically indistinguishable (that is, it looks and tastes identical) from the actual drug being studied.” In a placebo-controlled study, “patients receiving the new treatment are compared with those which receive a placebo.”
In addition to the primary endpoint or goal as measured on the PANSS scale, Aristada also managed to meet its secondary endpoint measured by the Clinical Global Impression-Improvement assessment compared to a placebo.
Use of Aristada, we should note, may lead to side-effects like insomnia, akathisia, and headache. According to the FDA, the Otsuka/Lundbeck Allliance’s Abilify Maintena can lead to increased risk of death in elderly people with dementia-related psychosis and neuroleptic malignant syndrome on rare occasions. FDA also notes side-effects for Novartis’s (NVS) Clozaril as agranulocytosis, seizures, myocarditis, increased risk of death in elderly people with dementia-related psychosis and other respiratory and cardiovascular side-effects. Use of Johnson & Johnson’s ( JNJ ) Invega Sustenna (through its subsidiary Janssen Pharmaceuticals) can lead to increased risk of death in elderly people with dementia-related psychosis and neuroleptic malignant syndrome on rare occasions, change in heart rhythm and Tardive Dyskinesia. On December 11, 2014, the FDA warned that Pfizer’s (PFE) Geodon can lead to rare but serious skin reaction, Drug Reaction with Eosonophilia and Systemic Symptoms (or DRESS).
Aristada is a once-monthly injection. Approved in three dosage strengths of 441 mg, 662 mg, and 882 mg, it allows physicians to adjust the therapy according to patients’ needs.
Additionally, the 882 mg dosage has been approved to be delivered once every six weeks to schizophrenia patients. Longer dosage duration is an important characteristic that should help the drug strengthen its position in the LAI (long-acting injectable) atypical antipsychotics market.
Ease of use
Aristada is administered with a pre-filled, ready-to-use, non-refrigerated syringe. Additionally, the 441 mg dosage can be injected on the patient’s deltoid or gluteal muscles.
WebMd defines deltoid muscles as “the large muscles, roughly triangular in shape, that stretch from the clavicle (collarbone) to the humerus (the long bone in the upper arm) and so cover the shoulders.” When the deltoid “is contracted (flexed), it moves the arm away from the side of the body.” Gluteal muscles are the muscles that form the buttocks. The high ease of use of Aristada is thus further expected to increase the uptake of the drug.
Investors can get exposure to Alkermes’s (ALKS) new schizophrenia drug, Aristada, while avoiding excessive company-specific risks by investing in the First Trust NYSE Arca Biotech Index Fund (FBT). Alkermes accounts for 3.68% of FBT’s total holdings.
Read the next part of this series for a look at Alkermes’s launch strategy for Aristada.
Update: We have revised this post to include further discussion of possible side-effects.
Correction: This post originally claimed that Abilify Maintena belonged to Bristol-Myers Squibb. We have since revised to indicate that it belongs to the Otsuka/Lundbeck Alliance. We regret this error.
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