Question: Why were the four drugs, Oxitriptan, Piracetam, Silver Protein Mild, and Tranilast, NOT approved for inclusion in the Bulks List?

Answer:

Note: We will cover the reasons for each of these, as provided by the FDA, covering one drug each week so all the information presented will be available to our readers. This is straight from the FDA's presentation.

1. OXITRIPTAN

Oxitriptan, also known as 5-hydroxytryptophan (5-HTP), was evaluated as a treatment for depression and insomnia. It is a hydroxylated form of a naturally occurring amino acid, tryptophan. Oxitriptan is well characterized physically and chemically. However, there are significant safety concerns related to its use. Based upon its mechanism of action, concomitant use of oxitriptan with antidepressant drugs could result in serotonin syndrome, a serious and life-threatening drug interaction. Additionally, medications used to treat depression have been linked to an increase in suicidal thinking and behavior. There are no data to suggest that oxitriptan would be free of similar risks, and compounded drugs do not include labeling that would adequately warn physicians and patients of such risks. Other potential adverse reactions include moderate gastrointestinal effects, which are common upon administration of oxitriptan.

Data supporting the efficacy of oxitriptan for depression are limited, and there is no evidence to support long-term efficacy of oxitriptan for the treatment of this chronic disease. Depression is a serious and potentially life-threatening condition, and there are multiple FDA-approved antidepressants that have been shown to be safe and effective in their approved forms that are appropriately labeled. Regarding the use of oxitriptan to treat insomnia, the clinical trials examining insomnia were too poorly designed and/or executed to assess efficacy. There are multiple FDA-approved drug products available for the treatment of insomnia. The length of time oxitriptan has been used in compounding is uncertain, although it has been discussed in scientific journals dating back approximately 40 years.

On balance, the physiochemical characteristics, the safety concerns, lack of evidence of effectiveness, and historical use of oxitriptan weigh against inclusion of this substance on the 503A Bulks List. In particular, the Agency's proposal regarding this substance is based on the seriousness of the safety concerns related to the use of oxitriptan for depression in lieu of or causing a delay in the use of an approved product, the lack of adequate warnings that would inform patients and prescribers of the risks associated with taking an oxitriptan product, and the availability of approved drug products for the treatment of depression, a potentially life-threatening condition. FDA proposed to the PCAC that this substance not be included on the 503A Bulks List (Ref. 7). At its meeting on June 17, 2015, the PCAC voted not to include oxitriptan on the list (Ref. 4). The proposed rule would not place oxitriptan on the 503A Bulks List.

Loyd V. Allen, Jr., PhD, RPh
Editor-in-Chief
International Journal of Pharmaceutical Compounding
Remington: The Science and Practice of Pharmacy Twenty-second edition

News

The FDA Supports Industry Move to Continuous Manufacturing.

Three years ago, J&J's HIV drug Prezista was the only product approved by the FDA to be produced with continuous manufacturing (CM). Now, there are four companies manufacturing five approved products using CM processes. Twenty others are on the road to their own approvals.

This ultimately moves the industry from batch processing into advanced manufacturing processes. "Drug makers won't switch to these systems until we create a clear path toward their adoption, and provide more regulatory certainty that changing over to a new manufacturing system won't be an obstacle to either new or generic drug approvals," Commissioner Scott Gottlieb said in a statement. "The FDA recognizes that it'll require additional investment in policies and programs that'll provide regulatory clarity to enable these new methods to be more quickly and widely adopted."
https://www.fiercepharma.com/manufacturing/gottlieb-throws-fda-weight-behind-industry-move-to-continuous-manufacturing

The FDA Approves Colchicine Oral Liquid Formulation for Gout
Gloperba, (Colchicine oral solution) 0.6 mg/5 mL has become the first liquid formulation of the therapy approved by the US FDA for the preventive treatment of gout flares. The product, from ROMEG Therapeutics, is for the US market for colchicine products currently valued at about $800 million. Existing therapies do not adequately address the physician's need to adjust dosages of colchicine to manage the toxicity profile for patients with renal and liver impairments, side effects, common drug-to-drug interactions, and age-related health disorders, explained the FDA, and the approval of Gloperba addresses a significant unmet and underserved medical need. https://www.mdmag.com/medical-news/fda-approves-liquid-colchicine-formulation-for-gout

"Digital Skin" Could Revolutionize New Drug Development
Tata Consultancy Services (TCS) is currently looking at ways to develop and administer drugs more efficiently, economically, and ethically. The firm has patented a new computer model which it says could not only completely change the way drugs are delivered into the body but reduce the need for animal testing in the years ahead. Called "digital skin," the innovation is designed for both personal care and pharmaceutical companies on how to deliver drugs painlessly through the skin, rather than through tablets, capsules, injections, or other invasive methods.

TCS' digital skin is described as a digital replica of every distinct layer of skin that the firm explains enables researches to explore hundreds of thousands of molecule and drug combinations. Testing using the digital skin is not only more accurate but is better than animal skin because the latter is not the same as human skin. The animal models don't replicate human behavior, which means that, quite often, your drug fails in later stage clinical trials.
https://www.forbes.com/sites/leebelltech/2019/02/27/a-digital-skin-innovation-could-revolutionize-new-drug-development/#f669c8675343

Did You Know ...

...that Winston Churchill said the following?

   "The main vice of capitalism is the uneven distribution of prosperity.
    The main vice of socialism is the even distribution of misery."

Tip of the Week

An observation: It is interesting and disconcerting that countries that have been economically, socially, and politically strong and successful adopt an ideology of socialism that takes the country downhill. It seems that many do not learn from history and put a failed ideology above common sense and reality.

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