FDA Approved Heron's Sustol To Prevent Chemotherapy Induced Nausea and Vomiting

After being rejected twice, Heron Therapeutics Inc.'s long-acting injection to prevent chemotherapy induced nausea and vomiting has finally been approved by the U.S. Food and Drug Administration, making it biotech's first regulatory approval. On Wednesday, the company's shares were said to be 17 percent up at $23.35 in premarket trading.

Nausea and vomiting are the most common acute side effects of chemotherapy. According to the National Institute of Health, it is experienced by up to 80 percent of patients undergoing the treatment, cnbc.com reported. Other management for chemotherapy-induced nausea and vomiting (CINV) includes the Palonosetron injection, which generally takes effect for 48 hours or less. However, Heron's new long-acting injection could last up to five days, according to a statement issued by the company.

"Sustol appears to have gotten a favorable label ... and the approval removes a major overhang on the stock," Leerink's Jason Gerberry wrote in a note. A report by Reuters said that in April, the FDA found no glitch in Sustol's marketing application, after numerous times of postponing the decision on the drug, first in January and then later in February. The drug was approved to be combined with other agents to manage nausea and vomiting brought about by some forms of chemotherapy, except platinum-based regimens, Heron said.

Not having platinum-based therapies from the label is a little disappointing for the company, because Sustol has showed a good response in patients in this particular type of chemotherapy, wrote Cowen & Co's Boris Peaker. It also means that the total number of people that can be managed by Sustol will decrease by about 7 percent. Some of the most common adverse effects brought by the use of anti-nausea drug includes headache, constipation, fatigue, diarrhea, insomnia, abdominal pain, dyspepsia, dizziness and asthenia which is abnormal physical weakness or lack of energy.

Patients may see several reactions in the injection site following administration like pain, bleeding, infection, tenderness, nodules, induration and swelling. Tech Times reported that some of these injection site reactions may occur two weeks or more after being injected with Sustol. Meanwhile, Heron has not yet said how much Sustol costs, although the company it said it would reference recently approved treatments for CINV. However, industry experts approximate it to be around $200 per patient.