FDA Approves Botanical Drug

The U.S. Food and Drug Administration (FDA) recently approved crofelemer (Fulyzaq™) to treat diarrhea symptoms associated with antiretroviral therapy for HIV/AIDs.

This is only the second botanical prescription drug to be approved by the FDA. Sinecatechins (Veregen®) was approved as a treatment for external genital and perianal warts in 2006.

Although current antiretroviral drugs cannot cure HIV/AIDS, they may suppress the virus, even to undetectable levels. Individuals taking antiretroviral drugs frequently experience side effects such as nausea and diarrhea. According to the statement issued by the FDA, taking crofelemer (Fulyzaq™) twice daily may relieve the associated diarrhea side effects.

Crofelemer (Fulyzaq™) is derived from the red sap of the Croton lechleri plant, also called Sangre de grado. Sangre de grado (the Peruvian name) or sangre de drago (the Ecuadorian name), meaning "blood of the dragon," is a medium-sized tree that grows in the upper Amazon region of Peru, Ecuador, and Colombia. It has large, heart-shaped, green leaves and greenish-white flowers. Upon injury to the bark of the tree, a dark red resin spills out of the tree. Sangre de grado is still used in traditional medicine in South America, where it is used for hemorrhaging and wounds, and as an antiseptic. It is also used for protection against ulcers, including those of the stomach, mouth, throat, and intestines; as an antiviral, anticancer and antidiarrheal agent; and topically for skin conditions and insect bites.

For more information about sangre de grado, please visit Natural Standard's Foods, Herbs & Supplements Database.

Comments

[Amber]

Times are changing, and fast. I'm sure in the next couple years, we'll be seeing more and more of these botanicals become FDA approved. This is good news on a number of fronts. First, if it's an FDA approved drug, then there's more regulation. Secondly, this opens up the doors for patients and health care providers to explore non-traditional options. Lastly, this may encourage more research in this area, as I'm sure there's going to be an expensive market for this (=$$$).

[Zach]

This is interesting...I am very surprised to find that Fulyzaq is only the second botanical Rx drug approved by the FDA. I guess I find this line a little blurry. What makes a botanical Rx vs. an herbal supplement? Isn't aspirin just refined willow bark?

[MS]

It is great to see natural products being approved by the FDA for a labeled indication. When you look up crofelemer on Clinical Pharmacology, it is only approved for diarrhea. Dosage and safety for crofelemer is not established for adolescents, children, infants and neonates. Therefore more research is needed in those areas. It will be interesting to see the transition of natural products to be used as part of hospital treatment guidelines. Fulyzaq™ is manufactured by Salix Pharmaceuticals, Inc. which was founded in 1989, making it a fairly small and new pharmaceutical company. Hopefully more pharmaceutical companies put time and money into researching natural products.

[ac]

I'm surprised that this is only the second botanical that is FDA approved. It would be interesting to see if pharmacy benefits will cover this medication. Can anyone find how "Fulyzaq" is pronounced? Sounds as if the drug companies are using z's and q's to make their drug sound as like it's from the future!

[kl]

I'm hoping that Fulyzaq doesn't cause some other adverse effect in this patient population. The chain of treating the adverse effects of one medication with another medication may be endless here. According to the package insert, Fulyzaq's side effects include bronchitis, cough, upper respiratory tract infection, increased bilirubin and flatulence. It scares me to think that immunocompromised patients taking this drug may have an increased risk of upper respiratory tract infection and bronchitis. I will be interested to see what phase four clinical trials reveal about the true benefits of Fulyzaq.

[bz]

I am thrilled to see an approval for a product specifically aimed at targeting diarrhea in patients on antiretroviral HIV/AIDS therapy. Diarrhea is one of the biggest complaints I get from patients on antiretroviral therapy for HIV and it really does decrease compliance with these medications, which is a major inhibitor to optimal treatment of the disease. Fulyzaq is a major breakthrough and will hopefully contribute to significant improvements in adherence to antiretroviral therapy.

[Sara Berg]

I think this could be very important in the adherance of lots of medications. Resistance to antiretrovirals can happen very quickly in HIV/AIDS patients, but resistance is also a huge problem with antibiotics. I have had many patients unwilling and/or unable to finish antibiotic regimens due to nausea. Anything we can do to lessen this could help slow the development of antibiotic resistant organisms.

[AM]

I agree with the previous posters. This is a big deal. With so many of our drugs based on botanicals, it's good to see that so much money is going into botanical products research. I hope it increases the awareness of how important preservation of the worlds rainforests is. With so much botanical diversity, this isn't the first, and can't be the last botanical drug on the market.

[km]

Alternative and complementary medicines have been used both as prescription and over the counter drugs in many different countries. It’s very interesting and exciting to see a change in the direction of standard treatments in the United States as well.

[ac]

In a trial of >300 patients, the investigators found that 17.6% of those taking Fulyzaq had a clinical response vs. 8% of those taking placebo. The investigators even found that the effects persisted up to 20 weeks in some participants. I think these numbers are very clinically significant especially when considering that this drug may help increase adherence to HIV/AIDS therapy and help prevent resistance.

[pc]

This is a very interesting breakthrough for herbal medicine, and clearly a direction that medicine should be moving. There are an infinite number of discovered and undiscovered natural compounds that could be helpful in drug development, from unknown tree bark compounds to spider venoms. I'm sure we will see more approvals for Fulyzaq as well; it seems like it could be helpful for more than just HIV/AIDS patients. More research into other groups that may benefit from Fulyzaq treatment is clearly warranted.

[BC]

I also agree that it would be interesting to see other studies done on a patient population of different disease states to see if Fulyzaq is as effective. It is great that more studies are being conducted to discover potential therapy.

[AR]

I think this is great, but why was it only studied and approved for use in HIV/AIDS patients on antiretroviral therapy? I wonder if Fulyzaq™ would also be effective for patients experiencing diarrhea from other medications, like metformin. I hope there will be more studies published about Fulyzaq™ in the future that include patients with diarrhea due to other medications.

[kl]

This seems like a great scientific finding for patients with HIV/AIDS who continuously suffer with diarrhea secondary to antiretroviral therapy. Overall, the clinical trials seem to show a significant benefit in decreasing stool weight as compared to placebo. Also, according to Natural Standard, Sangre de grado (the plant in which Fulyzaq is derived) has an evidence grade of C for herpes virus. Although more studies are needed for this and other indications, I think this is only the beginning of herbs and supplements, such as Fulyzaq, being approved by the FDA.

[JS]

It’s great that drug companies are investing money in researching botanical species for drug development. Lots of common drugs originated from plants such as aspirin, warfarin, and digoxin. I was interested in Fulyzaq and found that it’s a first-in-class and works by preventing chloride secretion through inhibiting chloride channels. I also found that it works locally in the GI lumen and has very little systemic absorption. I’m sure by not being extensively absorbed systemically this prevents some possible drug interactions especially in a patient population that is taking multiple antiretroviral medications.

[Ashley Tewksbury]

It's awesome to see herbals getting FDA approval!