Release date: 2017-12-25
Agile Pharmaceutical's low-dose combination hormonal contraceptive patch Twirla (AG 200-15) has recently been rejected by the US Food and Drug Administration (FDA). Affected by this bad news, the company's share price plummeted, and its stock price fell nearly 70% before the market.
The US FDA said Agile needed to reconsider its adhesion test method and address the problems found in third-party manufacturer Corium's facility inspections. The FDA questioned the in vivo adhesion properties of Twirla and its potential relationship with the results of a three-stage clinical trial. The response letter contains recommendations for developing tests during the manufacturing process to ensure the quality and in-body adhesion of commercial-scale products, as well as completed drug specifications and adhesion release test methods.
The FDA also recommends that the company evaluate the in vivo adhesion properties demonstrated in the three-stage clinical trial. Finally, the FDA recommends that the company address the impact of clinical trial subject patch compliance and exit rates. The FDA has not identified any specific issues related to Twirla safety.
Twirla, also known as AG200-15, is a weekly clinically prescribed prescription contraceptive patch. Twirla is a combined hormonal contraceptive or CHC patch containing the active ingredient ethinyl estradiol or EE, a synthetic estrogen, levonorgestrel or LNG is a progestogen, a synthetic steroid Hormones, both of which have established efficacy and safety in combination low-dose oral contraceptives currently on sale.
The FDA rejected the drug application in 2013 and asked Agile to conduct a new clinical trial and provide more information about the manufacturing process. Currently, there is only one other type of contraceptive patch available in the United States, and the patch is limited due to its dosage and physical properties. The purpose of designing Twirla is to address these limitations, which is the second time the contraceptive patch has been rejected by the US FDA.
Agile Chairman and CEO Al Altomari said in a statement: "We are disappointed that the company is evaluating the FDA's response and intends to meet with the FDA as soon as possible to discuss the issues raised in the response letter and discuss Twirla's approval path. The company will work closely with the FDA to resolve the issues raised in the letter as soon as possible."
Agile was incorporated in Delaware on December 22, 1997. The company is a women's health professional pharmaceutical company focused on the development and commercialization of new prescription contraceptive products. Agile's candidate products are designed to provide women with more convenient and more compliant contraceptive options. Agile has developed a patented transdermal patch called Skinfusion that aims to provide a patch that is superior to currently available, optimizing patch adhesion, stability and patient acceptance.
Source: Sina Pharmaceutical News
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