As an ethical pharmaceutical company, we strive to have transparency in pursuit of good science and medicine. Information regarding clinical trials is important to patients who might be potential study participants and their physicians. As a publicly traded company, we will have practices in place to ensure protection of intellectual property and proprietary processes as well as individual privacy.
The Trial Results section includes summaries for studies of FDA-approved drugs completed prior to 2014. Results for applicable clinical trials that completed after can be viewed on www.clinicaltrials.gov.
Each summary includes a brief description of the study design, methodology and protocol-defined efficacy (predominantly Phase III and IV studies) and safety (all Phases) outcome results.
All information provided to the Trial Results section is intended to comply with relevant FDA regulations. The online availability of a summary may be delayed if Allergan needs to perform certain actions to seek intellectual property protection. Summaries may also be delayed from online dissemination due to embargoes mandated by peer-reviewed journals while the study manuscript is under consideration for publication.
Prior to the commercial availability of a drug, the Food and Drug Administration (FDA) evaluates the safety and efficacy data from clinical studies to approve the usage of the drug for a particular indication (e.g. medical conditions or diseases). Use of a drug is considered to be on-label if it is prescribed for an approved indication as provided in the U.S. Prescribing Information (Label) for the drug.
During clinical development and following approval, a drug may be studied for several indications. Use of a drug is considered to be off-label if prescribed for a non-approved indication for which clinical evidence of safety and efficacy has not yet been submitted to the FDA for review, or for which the FDA has not yet granted approval.
The clinical summaries are intended for fair-balanced disclosure of clinical evidence for completed studies, and are not intended for promotional purposes. The Trials Results is not meant to be a complete bibliography or reference about any drug, and more information may be available in the medical literature.
To view the trial results, select from the list of conditions/disease categories on the left navigation panel.