Otonomy is a biopharmaceutical company focused on the development and commercialization of innovative therapeutics for diseases and disorders of the ear. Otonomy conducts clinical trials to assess the safety and efficacy of its investigational drugs. The establishment of the safety and efficacy of these drug candidates helps us obtain approvals from regulatory agencies such as the FDA, which approvals are required before these drug candidates can be made generally available to patients. Otonomy encourages awareness of and participation in its clinical trials and believes that participating in clinical trials is the best way for patients to access investigational drugs prior to regulatory approval.
Currently, Otonomy does not make its unapproved drugs available on an expanded access basis. However, Otonomy encourages interested individuals to contact the company regarding potential participation in its clinical trials. The following is additional information regarding Otonomy’s expanded access policy in accordance with the 21st Century Cures Act:
1.) Contact Information. If you have any questions regarding potential participation in Otonomy’s clinical trials, please contact the Otonomy Clinical Trial Information group by phone at 1-844-OTO-INFO (1-844-686-4636), or by email at firstname.lastname@example.org. If you have any questions regarding Otonomy’s expanded access policy in general, please contact email@example.com.
2.) Request Procedures. If you contact Otonomy, please also include your contact information so Otonomy may follow-up with you directly.
3.) General Criteria. In the event Otonomy decides to consider expanded access use in the future, we will evaluate and respond to each expanded access request that it receives on a case-by-case basis.
4.) Anticipated Timing. If you contact Otonomy as described above, Otonomy anticipates that it will acknowledge receipt within ten business days.
5.) Clinicaltrials.gov Hyperlink. If Otonomy decides to make its products available on an expanded access basis in the future, this policy will be updated with a hyperlink to the expanded access record on clinicaltrials.gov after such record becomes active.
Otonomy may revise this expanded access policy at any time. Additionally, the posting of this policy by Otonomy shall not serve as a guarantee of access to any specific investigational drug by any individual patient.