FDA warns Sprout over Addyi Instagram post, clinical trial sponsor for lacking an IND
The US Food and Drug Administration (FDA) has warned Sprout Pharmaceuticals for the second time concerning its promotion of its hypoactive sexual desire disorder (HSDD) drug Addyi. The agency also sent a warning letter to a company for conducting a clinical investigation without submitting an investigational new drug application (IND).Addyi warning letter
FDA’s Office of Prescription Drug Promotion (OPDP) sent Sprout Pharmaceuticals a warning letter dated 29 May citing an Instagram post made by its CEO Cindy Eckert. The post promotes its drug Addyi (flibanserin) to treat certain premenopausal women with acquired generalized HSDD, without including any mention of the drug’s risks.
FDA noted that Addyi comes with a boxed warning that it can cause severe hypotension and syncope in certain cases and is contraindicated in people using concomitant moderate or strong CYP3A4 inhibitors, in those with hepatic impairment, and those with known hypersensitivity to Addyi. The labeling also includes warnings and precautions users should take to avoid hypotension and syncope due to alcohol use and other situations. It lists dizziness, somnolence, nausea, fatigue, insomnia, and dry mouth as the most common adverse events.
FDA said the post failed to fully disclose the drug’s indication and limitations on who can take it.
“By omitting the risks associated with Addyi, the post fails to provide material information about the consequences that may result from the use of Addyi and creates a misleading impression about the drug’s safety,” said FDA. “This omission is especially problematic from a public health perspective given the serious risks associated with the drug.”
“Additionally, the post fails to disclose Addyi’s limitations of use, including that it is not indicated for the treatment of HSDD in postmenopausal women or men, and that it is not indicated to enhance sexual performance,” the agency added. “This is especially concerning given the unqualified representation made in the post suggesting that Addyi is the ‘sex pill for women.’ This broad claim suggests that Addyi is indicated, among other things, to enhance sexual performance, which is particularly concerning given the limitations of use and serious risks of this product.”
This isn’t the first time that the company has been cited for failing to meet FDA’s regulations on promotional materials. OPDP sent a warning letter to Sprout on 31 August 2020 for a radio ad that similarly did not include important risk and indication information about Addyi. (RELATED: FDA warns Sprout for misleading Addyi come-on, Regulatory Focus 15 September 2020)
ABRI warning letter
In a letter dated 30 April, FDA issued a warning letter to American Behavioral Research Institute (ABRI) based in Florida for sponsoring a clinical trial of its Relaxium Sleep supplements, which have been promoted by celebrities such as Bill O’Reilly and former Gov. Mike Huckabee (R-AR) as a sleep aid.
FDA investigated ABRI between April and May of last year as part of its Bioresearch Monitoring (BIMO) Program and concluded that it failed to follow regulations regarding clinical investigations and human subjects protections.
Responding to a Form 483, the company argued that it was exempt from regulations because its product was a dietary supplement and not a drug, but FDA disagreed. The agency said that ABRI used the clinical trial to study the efficacy of Relaxium to mitigate and treat insomnia, which makes it a drug.
“Whether an investigational article is a drug or a dietary supplement depends on the intent of the investigation,” said FDA. “Based on the study design of Protocol ABRI-002, the investigational product, Relaxium, as used in the clinical investigation, was a drug as defined in section 201(g)(1) of the FD&C Act, because Relaxium was studied for use in the treatment of insomnia.”
While ABRI told FDA that there is no risk that it will violate clinical trial regulations in the future because it will not conduct any more clinical trials, the agency said it still wants a detailed corrective and preventive action plan (CAPA) and implementing procedures in case the company changes its mind and conducts studies that require INDs.
“As a sponsor, you are responsible to comply with IND requirements, including submitting and having in effect an IND before initiating a clinical investigation, and it is your responsibility to be aware of and to follow all applicable FDA regulations,” said the agency. “Your failure to submit, and to have in effect, an IND before initiating Protocol ABRI-002 with an investigational drug raises significant concerns about the safety and welfare of enrolled subjects, and raises concerns about the validity and integrity of the data collected during the conduct of this clinical investigation.”
Both companies were given 15 days to respond to FDA’s warning letters.
Sprout warning letter, ABRI warning letter
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